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8.0 - 13.0 years
6 - 9 Lacs
Ahmedabad
Work from Office
B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
5.0 - 10.0 years
3 - 8 Lacs
Vadodara
Work from Office
Key Skills Required: Hands-on experience with NAFDAC and Nigeria regulatory filings and West Africa Market Knowledge of CTD/eCTD dossier preparation Regulatory compliance for OTC/Pharma exports
Posted 1 month ago
3.0 - 6.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Key Responsibilities: Support the completion of statutory audits for JLL entities in the EMEA region Collaborate with Grant Thornton, our statutory auditors, to facilitate smooth audit processes Prepare and review statutory financial statements in accordance with local GAAP and IFRS Liaise with local finance teams to gather and validate financial data for reporting and audit purposes Perform accounting research and analysis to support decision-making processes and audit inquiries Contribute to the development and implementation of accounting policies and procedures related to statutory audits Prepare audit documentation and respond to auditor queries in a timely manner Identify and implement process improvements to enhance efficiency and accuracy in statutory audit processes Stay updated on changes in accounting standards and regulatory requirements across EMEA, assessing their impact on JLL entities Collaborate with cross-functional teams to resolve accounting issues and ensure consistency in financial reporting Qualifications: Bachelor's degree in Accounting, Finance, or related field 4-5 years of commercial experience in accounting or finance roles Experience with Big 4 accounting firms preferred Experience in conducting or supporting statutory audits Strong knowledge of IFRS and familiarity with local GAAP in EMEA countries Proficiency in Microsoft Office suite, especially Excel would be a plus Excellent analytical and problem-solving skills Strong attention to detail and ability to work with large volumes of data Effective communication skills in English, both written and verbal Ability to work independently and as part of a global team
Posted 1 month ago
3.0 - 6.0 years
5 - 8 Lacs
Chennai
Work from Office
Core Java/ JSP /EJB (SE/SSE Positions)-Chennai Posted On 30th Nov -0001 12:00 AM Location Chennai Role / Position SE/SSE level Core Java Engineers Experience (required) 3-6 Years Description Our client is the number one outdoor advertising company worldwide, the market leader in Europe and number 1 in Asia Pacific.Our client is looking for Asst Manager-Maintenance Candidate Profile Real estate experience in primary sale for at least 2-3 years Should have good communication skills Our client is one of the leading global real estate firms having offices across the world. Assistant Manager Send Resumes to girish.expertiz@gmail.com -->Upload Resume
Posted 1 month ago
2.0 - 4.0 years
4 - 6 Lacs
Pune
Work from Office
Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly document the research and analysis related to the financial activity and related entities of Clients Escalate issues to client and internal managers to bring issues to their attention promptly Independently handle clients and client calls establish self as a valued partner Help knowledge management endeavor by sharing process knowledge and best practices within the teams Communicate effectively and efficiently with relevant internal and external parties to obtain KYC documents Have a thorough understanding of the clients business and related parties to monitor clients activities for unusual transactions Perform further investigation on identified suspicious client and clients transactions and report to KYC/AML compliance officer Qualification and Skills Bachelors Degree (B.Com, BBA, BBM, BCA) / Masters Degree (M.Com, MBA, PGDM). 2 to 4 years of experience and knowledge of KYC, AML, and Due Diligence Should be able to understand, manage and calculate risks Should be good with logical and quantitative abilities
Posted 1 month ago
2.0 - 4.0 years
4 - 6 Lacs
Mumbai
Work from Office
Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly document the research and analysis related to the financial activity and related entities of Clients Escalate issues to client and internal managers to bring issues to their attention promptly Independently handle clients and client calls establish self as a valued partner Help knowledge management endeavor by sharing process knowledge and best practices within the teams Communicate effectively and efficiently with relevant internal and external parties to obtain KYC documents Have a thorough understanding of the clients business and related parties to monitor clients activities for unusual transactions Perform further investigation on identified suspicious client and clients transactions and report to KYC/AML compliance officer Qualification and Skills Bachelors Degree (B.Com, BBA, BBM, BCA) / Masters Degree (M.Com, MBA, PGDM). 2 to 4 years of experience and knowledge of KYC, AML, and Due Diligence Should be able to understand, manage and calculate risks Should be good with logical and quantitative abilities eClerx Financial Markets offers consulting, technological innovation, and process management expertise to uniquely solve operational challenges for financial organizations worldwide. With nearly two decades of industry experience, complemented by smart automation and robotics, our team of experts delivers holistic solutions across the trade lifecycle, change management, data analytics, compliance, cash securities operations, document digitization and generation, and outreach.
Posted 1 month ago
2.0 - 4.0 years
4 - 6 Lacs
Mumbai
Work from Office
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
Posted 1 month ago
2.0 - 4.0 years
4 - 6 Lacs
Pune
Work from Office
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
Posted 1 month ago
8.0 - 12.0 years
10 - 14 Lacs
Vadodara
Work from Office
About the Role: We are looking for an experienced and detail-oriented Regulatory Affairs Executive/Assistant Manager to join our team in the pharmaceutical industry. The ideal candidate will have in-depth knowledge of national and international regulatory requirements and a proven track record in handling regulatory submissions, dossier preparation, and compliance for pharmaceutical products. Key Responsibilities: Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines. Ensure timely submission and follow-up of applications with regulatory authorities. Maintain up-to-date knowledge of changes in drug regulatory environments and communicate impacts to relevant departments. Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation. Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards. Assist in handling product labelling, artwork approvals, and packaging compliance. Respond to regulatory queries and deficiencies from health authorities in a timely manner. Candidate Profile: Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical sector. Strong understanding of regulatory frameworks. Experience with dossier preparation in CTD/eCTD formats. Familiarity with regulatory submission tools and document management systems. Excellent communication skills, both written and verbal. Strong analytical and problem-solving skills. Detail-oriented with the ability to manage multiple projects and deadlines.
Posted 1 month ago
5.0 - 10.0 years
6 - 15 Lacs
Thane
Work from Office
Education : Bachelor/ masters degree in a related field (Pharmacy or Chemistry); Diploma in Regulatory Affairs. Location : Thane Experience: 5-10 years of proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets & experience in injectables In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing. Hands-on experience with regulatory document preparation and review. Strong understanding of QbD principles and ability to analyze trend data. Domain / Functional Key Skills: Keeping up-to-date with changes in regulations and ensuring compliance. Proficiency in preparing, reviewing, and submitting regulatory documents. Ensuring all necessary documentation for product approval is in place, complete, and accurate. Email : monisha.lahiri@randstad.in
Posted 1 month ago
4.0 - 9.0 years
30 - 32 Lacs
Bengaluru
Work from Office
: 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 well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance 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 well support you 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.
Posted 1 month ago
3.0 - 5.0 years
3 - 6 Lacs
Bengaluru
Work from Office
Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.
Posted 1 month ago
3.0 - 5.0 years
0 Lacs
Navi Mumbai
Work from Office
1. Compilation of Post Approval requirements i.e. Annual Reports, CBE-0, CBE-30, PAS, 15-Day Alert Report, PADER etc., ensuring that quality standards are met and submissions meet strict deadlines. Provident fund Office cab/shuttle Health insurance Annual bonus
Posted 1 month ago
1.0 - 3.0 years
3 - 3 Lacs
Bengaluru
Work from Office
Seeking candidate with hands-on experience in compiling/reviewing ACTD & CTD dossiers, regulatory documentation, and timely submissions. Must coordinate with teams, follow regional guidelines, and manage multiple projects efficiently.
Posted 1 month ago
3.0 - 6.0 years
2 - 7 Lacs
Pune
Work from Office
Description. Sr Regulatory Associate (EU mkt exp, Module 1). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Minimum 3 years of experience in the EU regulatory environment.. Basic understanding of regulatory procedure, including authoring of Module 1 documents, cover letters, and application forms.. Strong knowledge of regulatory systems such as Veeva Vault, DMS and RIMS. Responsibilities. Essential Functions For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:. Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.. Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.. Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.. Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.. Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.. Attends client meetings as needed and builds client relationship in support of projects and deliverables.. Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.. Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.. Assists in training and mentoring of team members depending upon project requirements.. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.. Qualifications. BS/BA degree or equivalent practical experience.. Experience in a work-related area preferred.. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Strong analytical skills.. Ability to work independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less
Posted 1 month ago
2.0 - 4.0 years
8 - 12 Lacs
Pune
Work from Office
Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less
Posted 1 month ago
5.0 - 10.0 years
11 - 15 Lacs
Pune
Work from Office
Description. Sr Regulatory Consultant (Biologics/Biosimilars). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Primary Skills required. Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses.. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications.. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH).. Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development.. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables.. Experience with post-approval changes, tech transfers, and product lifecycle management.. Excellent written communication, scientific writing, and document organization skills.. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars.. Secondary Skills Required. Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance.. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics.. Qualifications. Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less
Posted 1 month ago
2.0 - 5.0 years
3 - 7 Lacs
Noida
Work from Office
Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, auditing standards, and regulatory requirements, the Statutory Audit Team plays a critical role in the system. About the role: 1. Oversee and manage the general accounting functions, including, but not limited toaccounts payable, accounts receivable, general ledger, and taxes 2. Help with quarterly and year-end financial audit activities and the annual corporate financial controls audit 3. Assess current practices and procedures, and make recommendations for improvements 4. Prepare, review, and analyze financial statements to ensure accuracy and completeness 5. Perform ad hoc analysis and projects as requested 6. Supervise and/or manage general ledger accounting functions 7. Develop staff by managing performance, setting goals, providing ongoing training, and maintaining strong employee relationships 8. Work with auditors to ensure correct and timely closing and reporting at year-end Expectations/ : 1. Creative and dedicated individual who will fit with our collaborative culture 2. Cohesively work with a lot of people, across functions and teams every day 3. Coordinate with other departments for compatibility of all aspects of each project 4. Develop comprehensive project plans along with key stakeholders 5. Program manage initiatives that are driven centrally for Technology improvements 6. Track Program/Project performance, specifically to analyze the successful completion of short- and long-term goals 7. Engage with various Business & Technology Teams within Paytm to identify common bottlenecks esp. on Technology front 8. Enable and encourage use of common services to increase the speed of development and execution 9. Smart thinking and clear communication 10. Use and continually develop leadership skills Superpowers/ Skills that will help you succeed in this role: 1. 2 to 4 years of progressive accounting experience, with a portion of it being in a supervisory role 2. Thorough knowledge of Ind AS GAAP 3. Excellent verbal and written communication abilities across all level of an organization 4. Strong leadership skills with a dedication to driving and achieving results 5. Knowledge of employee relationship building and performance management techniques 6. Advanced Microsoft Excel skills. Experience with other financial systems. Education Chartered Accountant. Why join us: 1. A collaborative output driven program that brings cohesiveness across businesses through technology 2. Improve the average revenue per use by increasing the cross-sell opportunities 3. A solid 360 feedbacks from your peer teams on your support of their goals 4. Compensation: If you are the right fit, we believe in creating wealth for you With enviable 500 mn+ registered users, 21 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants – and we are committed to it. India’s largest digital lending story is brewing here. It’s your opportunity to be a part of the story!
Posted 1 month ago
5.0 - 10.0 years
5 - 10 Lacs
Pune
Work from Office
Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Markets, LATAM, ROW International @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.
Posted 1 month ago
3.0 - 8.0 years
5 - 7 Lacs
Bengaluru
Work from Office
Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates working in formulations may skip this job post.
Posted 1 month ago
19.0 - 25.0 years
0 - 0 Lacs
Nagpur
Work from Office
Job Description Responsible for overall engineering functions of OSD - plant Responsible for O&M of utility,HVAC, Water System and Process maintenance. Responsible for PM I Calibration I Facility maintenance and department safety functions. Responsible for regulatory I statutory audit compliance. Responsible for Preparation of maintenance reports budget and expenses control. Work Experience 20-25 years Education Graduation in Engineering or Electrical B.Tech in Engineering or Mechanical Engineering Competencies
Posted 1 month ago
8.0 - 12.0 years
7 - 13 Lacs
Pune
Work from Office
Role & responsibilities : As a Responsible Position , the Person, should be working as business owner / manager for the Export of Veterinary Pharma across world markets . Handle Existing clients , ensure business growth . Our business model is B2B 1.Business Development- Identify new product opportunities and develop promotional strategies. Participate in international exhibitions (CPhI, etc.) 2.Client Management : Present products to clients with technical detailing. Address formulation-related questions during negotiation. 3 Technical Evaluation: Understand product composition, dosage forms, and stability. Evaluate cost-effectiveness of formulations Suggest alternative formulations as per client/country requirement 4.Tender Participation- Support technical docs for government/institutional tenders Prepare product specs and stability data 6. Regulatory Interface- - Coordinate with regulatory teams to prepare CTD dossiers, GMP docs. - Handle queries from overseas authorities with the help of DRA team 7. Person will be responsible for Export / International Marketing for Pharma Formulation for EU, ROW, Latam Markets. Various Countries 8. Study EXPORT DATA , TRADE LEADS , B2B SITES 9. Co-ordination with client and factory for timely delivery of goods 10. The person should be having experience of 8-12 years in a reputed pharmaceutical formulation company for the respective region. 11. This role includes approaching and appointing foreign AGENT and implementation of planned activity to generate business and to meet the sales targets. 12. Handle Team Preferred candidate profile Good Communications Skills Honest, Hard Working Growth Mindset (Important) Ambitious & Positive Thinker 8-12 years of experience in Pharma Formulation Exports. Proficient English Writing / Speaking (Mandatory) Computer proficiency in MS Office, Excel, e-mail and internet functions.
Posted 1 month ago
0.0 - 5.0 years
5 - 8 Lacs
Nashik
Work from Office
We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.
Posted 1 month ago
1.0 - 5.0 years
5 - 8 Lacs
Madurai
Work from Office
We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.
Posted 1 month ago
5.0 - 10.0 years
6 - 11 Lacs
Durgapur
Work from Office
ICICI Prudential Life Insurance co Ltd is looking for SALES MANAGER - PSF EAST 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
Posted 1 month ago
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