119 Ra Jobs - Page 2

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency 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.

We are looking for a highly motivated and experienced Business Development Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 to 8 years of experience in the BFSI industry, preferably in used car finance. Roles and Responsibility Develop and implement effective business strategies to achieve sales targets. Build and maintain strong relationships with clients and stakeholders. Conduct market research and analyze competitor activity to stay ahead in the market. Collaborate with cross-functional teams to drive business growth. Identify and mitigate risks associated with business development activities. Monitor and report on business performance metrics. Job Requirements Strong knowledge of the BFSI industry, particularly in used car finance. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills. Experience working with financial institutions is an advantage. Ability to think creatively and develop innovative solutions. Any graduate can apply for this position.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-4 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee technical aspects of projects, ensuring timely completion and quality delivery. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and implement technical solutions to meet business needs. Conduct thorough analysis of technical issues and provide effective resolutions. Ensure compliance with industry standards and regulatory requirements. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Excellent problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills. Experience with technical tools and technologies is desirable. Ability to lead and motivate high-performing teams to achieve exceptional results.

Job Summary: Candidate should have experience in Regulatory Affairs Key Responsibilities: Regulatory Compliance: Review pricing submissions from pharmaceutical companies and enforce compliance with pricing policies. Reporting: Prepare and present reports on pricing data, trends, and regulatory compliance for internal stakeholders. Policy Support: Assist in the development and implementation of drug pricing policies and strategies. Skills: Education: Bachelors degree Candidate should be well-versed with DPCO provisions. Candidate should have complete know-how of operating the Online POrtal in terms of Registration of a product/production data/return filing. Price Regulation Process. Experience: Experience in pharmaceutical pricing, regulatory compliance, or related fields. Mandatory to have experience in NPPA compliance or CDSCO compliance and regulation Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Hiring of Drug Regulatory Affairs Specialist with 3-5 years’ experience at Loni, Ghaziabad, Uttar Pradesh 201102 Experience: 2-5 years in regulatory affairs within the pharmaceutical industry. Regards, Varun (Hr) -9718983381 varun.osg777@gmail.com

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating budgets and/or project financials. 2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above). 2+ years of work experience in change management PMO, PMP, Agile Methodology or Six Sigma Project Management Certification. Principal Roles and responsibilities Gathers stakeholder needs and goals with guidance and executes communication plan for project team and stakeholders. Forms project team, and manages and prioritizes the work of the project team by establishing schedules and task assignments, and tracking tasks of team members. Creates project goals and prioritizes deliverables with guidance from project stakeholders. Create roadmap and plan for change management, assess change impact. Apply a structured methodology and lead change management activities, support communication efforts, Manages multiple projects of small to medium size or complexity and applies up-to-date project management knowledge to meet deadlines. Builds and execute project plans for small- to medium-sized projects which include schedule and resource forecasting, stakeholder identification, method and frequency of communication, scope, and prioritization. Identifies project issues and risks and creates a risk mitigation plan for small- to medium-sized projects. Manages project performance (e.g., on time, on budget, within scope, and with quality) for projects of small to medium size or complexity. Promotes project vision and objectives within project team and ensures project objectives are met. Supports the compliance of project plans by following best practices and procedures. Promotes collaboration with diverse project stakeholders. Level of Responsibility Taking responsibility for own work and making decisions with limited impact; impact of decisions is readily apparent Solid understanding of how people go through a change and the change process with knowledge of change management principles, methodologies and tools. Using verbal and written communication skills to convey basic, routine information about day-to-day activities to others who are fully knowledgeable in the subject area. Completing tasks that require multiple steps that must be performed in a specific order, using directions or manuals that accurately document the steps necessary to perform the tasks. Using deductive problem solving is required to solve moderately complex problems; most problems have defined processes of diagnosis/detection; some data analysis may be required. Exercising some creativity may be required to troubleshoot technical problems or deal with novel circumstances. Minimum Qualifications: Bachelor's degree. 4+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Experience Level- 5+ Years, Project/Change certified + successfully delivered Shift timing- EMEA shift (3 pm IST to 12 am IST), but should be flexible based on business needs Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

About Antier Solutions Antier Solutions is a global leader in blockchain, DeFi, and tokenization , driving regulatory-compliant Web3 innovations. As the industry evolves, ensuring legal and regulatory compliance is critical for sustainable growth. We are looking for a General Counsel / Head of Crypto Compliance & Regulatory Affairs (initially outsourced) to lead c ompliance for token launches, fundraising, and Web3 business models while working with global regulatory bodies. This is a high-impact role , perfect for an expert in crypto law, fintech regulations, and international securities compliance. Role Overview: As the General Counsel / Head of Crypto Compliance , you will: - Oversee regulatory compliance for token sales, fundraising, and Web3 projects. - Liaise with global regulators (SEC, MAS, ESMA, DIFC, FCA, etc.) to ensure licensing and structuring. - Ensure adherence to AML/KYC, investor protections, and jurisdiction-specific legal frameworks. - Mitigate legal risks associated with crypto exchanges, DeFi protocols, and NFT marketplaces. - Develop internal legal policies to align with global securities, tax, and financial regulations. Key Responsibilities: 1. Legal & Regulatory Compliance for Web3 & Token Launches - Ensure full compliance for ICOs, IDOs, STOs, and private token sales. - Provide regulatory guidance on structuring utility vs. security tokens. - Work with securities and financial regulators to ensure legally compliant fundraising mechanisms. - Assess and mitigate legal risks related to smart contracts, tokenomics, and DAOs. 2. Global Licensing & Regulatory Affairs - Work with SEC (USA), MAS (Singapore), FCA (UK), ESMA (Europe), and DIFC (Dubai) on crypto licensing & approvals. - Support the acquisition of Virtual Asset Service Provider (VASP) licenses in multiple jurisdictions.- Develop cross-border compliance strategies for international Web3 operations. 3. AML/KYC, Investor Protection & Jurisdictional Compliance - Oversee AML (Anti-Money Laundering) & KYC (Know Your Customer) policies for token sales & DeFi platforms.- Ensure compliance with FATF Travel Rule, GDPR, and data privacy laws in crypto transactions.- Implement investor protection mechanisms to comply with securities and exchange laws. 4. Risk Management & Smart Contract Legal Audits - Conduct legal due diligence on Web3 projects before fundraising rounds.- Work with blockchain developers to audit smart contracts for legal risks. - Establish corporate governance frameworks for DAOs and decentralized projects. 5. Internal Legal Advisory & Policy Development - Draft terms of service, privacy policies, and compliance documentation for blockchain platforms.- Provide legal counsel on intellectual property rights for NFTs and metaverse projects. - Advise the executive team on emerging regulatory changes affecting the crypto industry. Key Qualifications & Experience: Must-Have: - 5-10+ years in crypto/fintech law, regulatory compliance, or legal advisory. - Deep understanding of crypto regulations, securities law, and DeFi compliance. - Experience working with global regulatory bodies (SEC, MAS, FCA, ESMA, DIFC, etc.). - Expertise in AML/KYC frameworks, FATF Travel Rule, and investor protection laws . - Familiarity with token classifications (security vs. utility) and Web3 fundraising structures. Preferred: . Experience with VASP licensing, DAO governance, and smart contract legal audits. . Strong connections with global law firms, compliance officers, and financial regulators. . Understanding of cross-border tax implications for digital assets and stablecoins. . Prior involvement in legal structuring for blockchain startups and crypto exchanges. Why Join Antier Solutions Lead compliance for cutting-edge Web3 projects in a legally evolving industry. Work with top-tier regulators, VCs, and blockchain pioneers. Shape tokenomics models and investor protections for high-growth crypto ventures. Be part of a global blockchain consultancy driving regulatory excellence. ApplySaveSaveProInsights

About The Role : Job TitlePB Emerging Markets, Associate LocationMumbai, India Role Description Deutsche Bank PB is one of the worlds leading global wealth managers. PB serves the holistic needs of 3 million clients and has a unique client proposition, especially for Family entrepreneurs, Ultra High Networth Individuals (UHNWI) and affluent customers. Leveraging its global network and expertise from across Deutsche Bank, it provides capital markets expertise and international solutions tailored to the individual needs of clients. These include wealth planning over generations and international borders, asset management with individual risk management, loans and deposits as well as the development of bespoke solutions for individuals or selected institutions in close collaboration with experts in Investment Banking and Asset Management. The role is part of a desk extension team in PB CFO and supports the CFO / Financial Reporting and Performance Management team, having a local reporting line in Mumbai. 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) 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 Preparation the flash and actual processes, including relevant explains, interacting with the regional/central CFOs and Performance Mgmt teams / business heads where required Timely and Accurate feed of Revenue and Net New Assets numbers in Pulse (Management reporting system) Ensuring timely completion of monthend process / quarter end and GGL restatement process Monthly / Weekly Revenue / Flow / Volume reporting & analysis for senior management Handling critical ESG reporting which gets published externally Conduct various ad hoc analysis and strategically address issues that are complementary to the regular planning and forecasting processes Assist CFO with restatements of PB Financials, New transactions review and accounting decision in co-ordination with Accounting Policy and Financial Controller team Deep diving financials and analyzing and providing meaningful commentaries, providing suggestion to business and being more efficient and pro-active in highlighting issue to business. Other CFO tasks as necessary Your skills and experience Academic qualifications in Business, Finance or related field preferably Chartered Accountant (CA) Prior relevant work experience of minimum 3 years Experience in Accountancy and Financial Controller or Performance Management related activities Aptitude for analytical tasks and ability to pull out the key messages Ability to constructively challenge senior colleagues Very Good advance Excel Working Knowledge Strong communication skills with excellent English, both orally and written Good knowledge of the financial sector How we'll support you Training and development to help you excel in your career 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

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

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

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

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.

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Middle east and southeast Asia Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation /extension Review of technology transfer documents Dossier compilation / dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share CVs on creyesha.macwan@alembic.co.in

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Europe & South Africa Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation form /extension form Review of technology transfer documents Dossier compilation / periodic updates in dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share cv on creyesha.macwan@alembic.co.in

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10 - 15 yrs. with dossier filling experience in MEXICO Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Should have through knowledge of Mexico submission. Should have understanding for requirements of Mexico. Should have understanding for review of regulatory documents like batch record, specifications, COAs, stability data, change control, process validation report etc. Should have knowledge of review of method validations, chromatograms, dissolution profile, raw data etc. Interested candidate can share cv on creyesha.macwan@alembic.co.in

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

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.

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

Roles and Responsibilities Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality Ensures the consistency and accuracy of layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings, tables, images, and footnotes applying Amgen submission readiness formatting guidelines to create professional documents Coordinates document collection with cross-functional team members and ensures publishing readiness of the documents Participates in collaborative team activities for noncomplex documents, including support to collect input from authors/reviewers Participates in the cross-functional document review process Participates in project management activities, i.e., timeline tracking and scheduling meetings with team members Learns and uses organizationally required authoring tools and technology platforms Attends cross-functional meetings with writers and departments, as appropriate, to share and gather information relevant for successful completion of assigned documents Documents in scope include, but are not limited toClinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator’s Brochures, local Risk Management Plans, noncomplex Original Protocols/ Protocol Amendments, Plain Language Protocol Summaries, and Informed Consent Forms Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides Compiles and maintains product-specific reference libraries across therapeutic areas Basic Qualifications Graduated with a Bachelor’s degree in science from an accredited college or university Preferred Qualifications 1-2 years of experience formatting, performing QC reviews, and managing the coordination of regulatory/clinical documents at a pharma/biotech or similar organization Some scientific or medical knowledge Some exposure to basic statistical and medical communication principles Strong oral and written communication skills Able to collaborate with others and build solid and positive relationships with cross-functional team members Able to work independently and problem solve Attention to detail and accuracy Organizational skills in time and project management, including ability to manage multiple projects simultaneously Strong knowledge of document management systems and typical office applications (eg, Microsoft Office, SharePoint)

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

We need Regulatory Affairs Officer for a Reputed Life Science Company of Ahmedabad.