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4.0 - 6.0 years

3 - 7 Lacs

Madurai, Tiruppur, Salem

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Truhome Finance is looking for Branch Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

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8.0 - 11.0 years

4 - 7 Lacs

Vijayawada, Visakhapatnam, Guntur

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Truhome Finance is looking for Branch Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

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10.0 - 12.0 years

6 - 10 Lacs

Madurai, Tiruppur, Salem

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Truhome Finance is looking for Branch Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

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7.0 - 12.0 years

22 - 27 Lacs

Bengaluru

Remote

EXPERIENCE: 7 to 12 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training the junior writers. SKILLS: • Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs & amendements, and Investigator Brochures (IBs) • Demonstrated excellence in focused/lean writing and editing following defined processes and templates • Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions • Understanding of clinical development process from program panning to submission, including clinical trial design • Communication skills commensurate with a professional working environment • Effective time management, organizational, and interpersonal skills • People management experience for more than 2 years • Customer focus • Comfortable following directions, templates, and structured processes for delivering documents for review and finalization • Able to work independently while maintaining communication with the Sponsor’s MW project manager • Ability to move across Therapeutic Areas to support business continuity and resource needs • Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines • Develop work plan and ensure adherence • Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion • Adherence to processes and Sponsor-defined best practices • Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements KNOWLEDGE REQUIREMENT: Scientific Knowledge • Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States • Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) • Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science • Understanding of medical practices regarding procedures, medications, and treatment for different disease states • Manage messaging for consistency with historical information and in alignment with agreed-upon strategy • Capable of providing insight, alternatives, and suggestions based on previous experiences • Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring • Experience writing protocols, amendments, CSR, and CTD summary documents Technology Skills • Expert authoring in MS Word, understanding of MS Word functionality • Experience working in document management systems; managing workflows eApproval/signatures • Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc. • Flexibility in adapting to new tools and technology • Capable of training writers/authors on the use of templates, guidelines, and tools RESPONSIBILITIES: • Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summarries), and other regulatory documents on investigational drugs in various stages of clinical development • Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process • Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines • Develop and maintain project plans & work plan for the team members • People management • Work as an active member of cross-functional teams representing Medical Writing • Coordinate and deliver document kick-off meetings with writers and cross-functional representatives • Ensure adherence to standard content, lean authoring, and messaging across team members • Ensure communication between members remain open and information is disseminated appropriately • Possible participation in the orientation and coaching of junior team members • Conduct appropriate literature searches and screening, as needed • Participate on Medical Writing department initiatives, as appropriate. • Research regulatory requirements to remain current in the regulatory landscape • Share lessons learned and best practices • Ensure compliance with company training and time reporting

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3 - 5 years

5 - 7 Lacs

Gurugram

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Skill required: Property & Casualty - Property and Casualty Insurance Designation: Insurance Operations Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? We help insurers redefine their customer experience while accelerating their innovation agenda to drive sustainable growth by transforming to an intelligent operating model. Intelligent Insurance Operations combines our advisory, technology, and operations expertise, global scale, and robust ecosystem with our insurance transformation capabilities. It is structured to address the scope and complexity of the ever-changing insurance environment and offers a flexible operating model that can meet the unique needs of each market segment.Experience in Property & Casualty Core Underwriting or Underwriting support serving Commercial Insurance Carriers or Brokers out of Shared Service centers or Third Party BPO Companies Extensive knowledge of end-to-end spectrum of services offered under the suite of General Insurance Underwriting Support and tasks doneSkills required:Rating, Quote, Policy Booking, Issuance, Mid-term endorsements, Renewals and an overview of ReinsuranceShould be able to collaborate well with Underwriters, Underwriting Assistants and Brokers as needed to be able to get closures on outstanding documentation Must have excellent communication both written and oral skills In this role, you will be managing workflow process and inventory handle policy maintenance inclusive of, contract amendments, customer & policy maintenance, broker of record changes. You will be managing terminations as needed in internal systems issuance of policy certificates to agents within desired timelines for Property, Auto, Workers Comp, Inland Marine, Travel and Marine Insurance (Commercial & Personal lines in the English Language) What are we looking for? Agility for quick learning Problem-solving skills Detail orientation Prioritization of workload Written and verbal communication Customer service attitude Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shiftsTechnical Role & Responsibilities Policy Servicing Experience and Mid Term Policy EndorsementsExperience of Mid term endorsements supporting Commercial Lines business NAM region preferred UK or EMEA can be subject to evaluationPreferably supported Workers Compensation and Auto Endorsements – Primary lines Types of Endorsements mentioned below:-Name Insured Changes Loss PayeePayroll ChangesExperience ModDriver Updates/Auto Id CardCertificate of InsuranceOut of Sequence endorsementsPremium AuditsBureau CritsBureau - NCCI Fillings Premium FinanceCancellations & ReinstatementsWaiver of Subrogation Qualifications Any Graduation

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2 - 4 years

3 - 7 Lacs

Mumbai

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About The Role The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism – KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs – establish self as a valued partner Build domain expertise across processes supported, assist in speedy remediation of issues, implement process improvements and build / enhance controls to prevent future escalations Responsible for ensuring Process documentation is maintained in an updated fashion at all times Functional & Technical Skills: Graduation (B.Com., BBA, BBM, BCA) / Post Graduation (M.Com., MBA, PGDM) 2 to 4 years of experience in KYC, AML, Due Diligence. You should be able to understand, manage and calculate risks. Should have basic knowledge of finance, trade life cycle, investment banking, and derivatives. Should be good with logical and quantitative abilities. Shift Timings – APAC/EMEA/NAM About Us At eClerx, we serve some of the largest global companies – 50 of the Fortune 500 clients. Our clients call upon us to solve their most complex problems, and deliver transformative insights. Across roles and levels, you get the opportunity to build expertise, challenge the status quo, think bolder, and help our clients seize value About the Team eClerx is a global leader in productized services, bringing together people, technology and domain expertise to amplify business results. Our mission is to set the benchmark for client service and success in our industry. Our vision is to be the innovation partner of choice for technology, data analytics and process management services. Since our inception in 2000, we've partnered with top companies across various industries, including financial services, telecommunications, retail, and high-tech. Our innovative solutions and domain expertise help businesses optimize operations, improve efficiency, and drive growth. With over 18,000 employees worldwide, eClerx is dedicated to delivering excellence through smart automation and data-driven insights. At eClerx, we believe in nurturing talent and providing hands-on experience. eClerx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other legally protected basis, per applicable law.

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2 - 4 years

3 - 7 Lacs

Pune

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About The Role The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism – KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs – establish self as a valued partner Build domain expertise across processes supported, assist in speedy remediation of issues, implement process improvements and build / enhance controls to prevent future escalations Responsible for ensuring Process documentation is maintained in an updated fashion at all times Functional & Technical Skills: Graduation (B.Com., BBA, BBM, BCA) / Post Graduation (M.Com., MBA, PGDM) 2 to 4 years of experience in KYC, AML, Due Diligence. You should be able to understand, manage and calculate risks. Should have basic knowledge of finance, trade life cycle, investment banking, and derivatives. Should be good with logical and quantitative abilities. Shift Timings – APAC/EMEA/NAM About Us At eClerx, we serve some of the largest global companies – 50 of the Fortune 500 clients. Our clients call upon us to solve their most complex problems, and deliver transformative insights. Across roles and levels, you get the opportunity to build expertise, challenge the status quo, think bolder, and help our clients seize value About the Team eClerx is a global leader in productized services, bringing together people, technology and domain expertise to amplify business results. Our mission is to set the benchmark for client service and success in our industry. Our vision is to be the innovation partner of choice for technology, data analytics and process management services. Since our inception in 2000, we've partnered with top companies across various industries, including financial services, telecommunications, retail, and high-tech. Our innovative solutions and domain expertise help businesses optimize operations, improve efficiency, and drive growth. With over 18,000 employees worldwide, eClerx is dedicated to delivering excellence through smart automation and data-driven insights. At eClerx, we believe in nurturing talent and providing hands-on experience. eClerx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other legally protected basis, per applicable law.

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2 - 4 years

3 - 7 Lacs

Chandigarh

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About The Role The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism – KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs – establish self as a valued partner Build domain expertise across processes supported, assist in speedy remediation of issues, implement process improvements and build / enhance controls to prevent future escalations Responsible for ensuring Process documentation is maintained in an updated fashion at all times Functional & Technical Skills: Graduation (B.Com., BBA, BBM, BCA) / Post Graduation (M.Com., MBA, PGDM) 2 to 4 years of experience in KYC, AML, Due Diligence. You should be able to understand, manage and calculate risks. Should have basic knowledge of finance, trade life cycle, investment banking, and derivatives. Should be good with logical and quantitative abilities. Shift Timings – APAC/EMEA/NAM About Us At eClerx, we serve some of the largest global companies – 50 of the Fortune 500 clients. Our clients call upon us to solve their most complex problems, and deliver transformative insights. Across roles and levels, you get the opportunity to build expertise, challenge the status quo, think bolder, and help our clients seize value About the Team eClerx is a global leader in productized services, bringing together people, technology and domain expertise to amplify business results. Our mission is to set the benchmark for client service and success in our industry. Our vision is to be the innovation partner of choice for technology, data analytics and process management services. Since our inception in 2000, we've partnered with top companies across various industries, including financial services, telecommunications, retail, and high-tech. Our innovative solutions and domain expertise help businesses optimize operations, improve efficiency, and drive growth. With over 18,000 employees worldwide, eClerx is dedicated to delivering excellence through smart automation and data-driven insights. At eClerx, we believe in nurturing talent and providing hands-on experience. eClerx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other legally protected basis, per applicable law.

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1 - 5 years

8 - 13 Lacs

Mumbai

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About The Role : Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

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4 - 9 years

30 - 32 Lacs

Bengaluru

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About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

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12 - 15 years

25 - 30 Lacs

Nagpur, Mumbai (All Areas)

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UpMan Placements is inviting applications for an exciting career opportunity with one of our esteemed clients from the Pharmaceuticals industry. Role : Senior Manager RA Location : Nagpur / Mumbai Reporting To : Director BD Role Requirement: Regular interaction and close co-operation with R&D, BD, Production and Logistics Responsible for the dossier filling & query responses of EU, Brazil, Canada & Row market Role Responsibilities: Develop and execute regulatory strategies to ensure timely product approvals. Preparation, review & submission of ECTD/CTD dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products Documents review QQF, Change control, specifications, Commercial specifications, artworks Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification. Co-ordination with external & internal clients. Updation and maintenance of database of dossier status. Fulfil requirement for site registration and GMP clearance/approvals Experience and Background: Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. 12+ years of experience in regulatory affairs within the pharmaceutical industry. Proven track record of successful regulatory submissions and approvals. Required Skills: Strong knowledge of global regulatory frameworks (FDA, EMA, MHRA, WHO, etc.). Excellent documentation, analytical, and problem-solving skills. Ability to interpret and apply regulatory guidelines and requirements. Effective communication and negotiation skills for interactions with health authorities. Strong project management and leadership abilities. Interested candidates can connect with Vanita at 7861882495 or email at vanita@upman.in

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7 - 10 years

3 - 7 Lacs

Hyderabad, Madhapur

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Job Title: Senior Regulatory Publishing Specialist Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR. Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines. Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Qualifications: Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/ Biopharma industry. Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation. Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels.

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6 - 8 years

14 - 17 Lacs

Hyderabad

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The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

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5 - 10 years

4 - 7 Lacs

Hyderabad

Work from Office

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets. Roles & Responsibilities: Responsible for maintaining data within the Regulatory Information Management (RIM) system Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system Serve as a Data Management SME within cross-functional collaborative initiatives Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives Provide support on creating, running and analysing reports for data streamline projects Develop and deliver training materials and presentations to a global audience Manage the protocol Amendment New Investigator (PANI) submission updates Manage 1572 forms for FDA submission Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance In depth understanding of the Veeva Vault system Good written and verbal communication skills Detail oriented Independent time management and prioritization skills Work efficiently with little support and minimal to no supervision Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect Critical thinking skills Appropriate software skills as required Strong analytical and problem solving, communication and presentation skills Good understanding of business complexity and project inter-dependencies Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus Fluent in English, both in oral and written communication Experience in supporting projects / improvement initiatives Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM Be open to working in a dynamic environment embracing change as a constant and adopting new technologies Working in global teams and matrix organizations Able to follow through on tasks and motivate others to meet deadlines Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

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2 - 4 years

3 - 7 Lacs

Hyderabad

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What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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7 - 11 years

8 - 13 Lacs

Hyderabad

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The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

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5 - 8 years

7 - 10 Lacs

Hyderabad

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The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

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6 - 10 years

8 - 13 Lacs

Navi Mumbai

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Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets Preferred candidate profile Key Skills: eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products. Must have exposure to in-licensed dossier filing and out licensing Candidates with 6+ years of relevant experience. Candidate must have experience on Bio pharma products

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5 - 8 years

3 - 7 Lacs

Bengaluru

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Skill required: Payroll - Payroll Process Design Designation: Payroll Operations Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsPayroll experience into US/UK/InternationalDesign processes for performing payroll preparation, pay-slip calculation, post-payroll registration (e.g. accounting booking, payments, social security), recurring statutory forms submission. What are we looking for? Ability to meet deadlines Ability to perform under pressure Collaboration and interpersonal skills Adaptable and flexible Written and verbal communication Payroll Organization Design Payroll Planning and Distribution Workday Payroll Accounting Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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1 - 2 years

1 - 2 Lacs

Surat

Work from Office

Knowledge of registration requirements and procedures in LATAM (e.g., Brazil, Mexico, Argentina, Colombia, Peru, Chile) and other ROW countries (e.g., Africa, CIS, Southeast Asia). Experience with dossier preparation in CTD/ACTD/non-CTD formats. Familiarity with country-specific labeling, packaging. Strong communication, coordination, and documentation skills. Proficient in MS Office, document management tools, and regulatory tracking systems. Dossier Preparation: Compile, review, and submit registration dossiers (CTD/eCTD formats) for domestic and export markets (e.g., ROW, semi-regulated, and regulated markets). Regulatory Submissions: Handle regulatory filings for new product approvals, renewals, variations, and lifecycle maintenance. Labeling & Packaging Compliance: Ensure that product labeling, artwork, and packaging components comply with the regulatory requirements of respective authorities. Communication: Coordinate with R&D, QA, QC, Production, and external partners to gather necessary documents for submissions. Regulatory Intelligence: Monitor and interpret global regulatory requirements and communicate relevant updates to internal stakeholders. Audit Support: Assist in preparation and support during audits and inspections by regulatory authorities. Documentation: Maintain regulatory records, track submission timelines, and ensure completeness and accuracy of submitted documentation. Product Registrations: Liaise with international clients and agents for timely product registration and license renewals. Compliance: Ensure all activities comply with applicable guidelines (CDSCO, USFDA, EU, WHO-GMP, etc.). Role & responsibilities Preferred candidate profile

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3 - 8 years

3 - 5 Lacs

Gurugram

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Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline

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13 - 16 years

19 - 27 Lacs

Gujarat

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About Company ReNew is a leading decarbonization solutions provider and the first Indian clean energy company to list on Nasdaq (Nasdaq: RNW). With 16.3 GW of commissioned and pipeline utility-scale projects, we are a global company with strong Indian roots. Founded in 2011, ReNew is at the forefront of fighting climate change by offering decarbonization solutions through utility-scale wind and solar offerings, green hydrogen, carbon markets, and energy storage. ReNew has been a pioneer in leveraging digital technologies to accelerate the transition to green energy and address the unique requirements of the B2B segment in India, where we are the market leader. Our mission is to play a pivotal role in meeting India’s growing energy needs in an efficient, sustainable, and socially responsible manner. ReNew is the world’s first clean energy company to be recognized as a Lighthouse by the World Economic Forum. In 2023, we were recognized among ‘Top 15 Climate Tech Companies to Watch’ by the MIT Technology Review. We are a recipient of the Sustainable Market Initiative’s Terra Carta Seal. The COP28 UAE Presidency presented ReNew the ‘Energy Transition Changemaker’ award for developing and deploying the country’s first round-the-clock power project. ReNew’s solar and wind energy projects currently contribute to 1.9% of India’s power capacity and are spread across 150+ sites and 18 Indian states. We have helped prevent 0.5% of India’s total carbon emissions and 1.1% of India’s total power sector emissions, in addition to generating around 130,000 jobs over the past decade Job Description Build and maintain strong working relationships with key government offices including GEDA, CEIG, GERC, Secretariat, and relevant Ministries for daily coordination and strategic engagement. Keep abreast of Renewable Energy (RE) policy developments at both State and Central levels and provide insightful analysis to internal stakeholders. Identify and pursue business development opportunities under segments such as: STU-connected projects Open Access (OA) Commercial & Industrial (C&I) initiatives Engage with regulatory authorities and policymakers to advocate for the introduction and/or amendment of favorable RE sector policies. Coordinate with departments at GETCO, GUVNL, SLDC, and DISCOMs to ensure timely processing of connectivity-related documentation and regulatory compliances. Serve as the liaison between internal business teams and external regulatory bodies to streamline approvals and minimize delays. Provide timely updates on regulatory changes, risks, and opportunities impacting current or upcoming RE projects in the region.

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3 - 5 years

3 - 4 Lacs

Chennai

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTDs and RA dossiers. Conduct document reviews to ensure compliance with drug regulatory affairs requirements. Provide expertise on dossier preparation, drug regulatory affairs, and related matters. Collaborate with cross-functional teams to achieve project goals. Ensure timely submission of regulatory documents to relevant authorities. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) from a recognized institution. 3-5 years of experience in pharmaceutical industry with a focus on drug regulatory affairs. Strong understanding of CTD, Document Review, Dossier Preparation, and RA processes.

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1 - 2 years

1 - 5 Lacs

Ahmedabad

Work from Office

GCS Medical College Hospital & Research Centre is looking for Executive - Quality to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

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1 - 4 years

2 - 6 Lacs

Hyderabad

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What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience. Roles & Responsibilities: Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Contribute to both front-end and back-end development using cloud technology Develop an innovative solution using generative AI technologies Conduct code reviews to ensure code quality and alignment to standard methodologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Stay updated with the latest trends and advancements Work closely with the product team, business team, and other partners Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Design and implement systems and processes to improve the reliability, scalability, and performance of applications Develop and maintain monitoring tools and dashboards to track system health, performance, and availability Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures Implement and maintain security measures to protect systems from unauthorized access and other threats What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline Have knowledge of ClinicalTrials.gov and EudraCT Have good knowledge of Regulatory Veeva Vault Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologiesScaled Agile (SAFe), ITIL, etc. Strong knowledge of information systems and network technologies Good-to-Have Skills: Strong knowledge of eCTD specification and highly regulated (GxP) systems Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytical/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform Certified (preferred) Soft Skills: Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

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