Senior Regulatory Affairs Associate
2 days ago
When our values align, there's no limit to what we can achieve. Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage Experience in handling CMC related health authority queries, and author responses to HA requests Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures). Preparation of documentation for different types of Variation procedures like Super Grouping Grouping and Work-sharing to the Marketing Authorizations. Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements. Author CMC components of Annual Reports and renewals (m 1/2/3), GMP submissions e.g., site registrations Providing regulatory impact assessment for any change control and identification of required documentation for EU/US submissions and other markets. Liaise closely with cross-functional members with aligned product responsibilities. Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates. Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault. Strong communications skills and ability to guide and mentor team members, and ability to work independently. Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations. Familiarity with EU Guidelines for QRD / Excipients.
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Regulatory Affairs Associate
4 days ago
Bengaluru, India Parexel Full time**_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...
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Regulatory Affairs Associate Ii
3 weeks ago
Bengaluru, India Whatjobs IN C2 Full timeRole: Regulatory Affairs Associate II Work location: Mumbai & Bangalore Summary: The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products....
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Regulatory Affairs Associate
1 week ago
Bengaluru, India Antal International Full timeJob Description **Job Title**: Regulatory Affairs Associate **Department**: Regulatory Affairs and Quality Compliance **Position at**: Bangalore **Position’s Objective & Summary**: Self-starter, executes the Regulatory strategy for obtaining registration approval of the company portfolio, according to plan. With limited supervision, coordinates and...
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regulatory affairs
1 week ago
Bengaluru, Karnataka, India Randstad MENA Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearJob Description Job Details This job offer closes 6 January 2026.SummaryLocation: Bengaluru, Karnataka Company: A client of Randstad India Type: Temporary Posted on: 7 November 2025 Reference Number: JPC Next StepsContact the recruiter Set a job alert Create an account Search jobs Randstad Professional We bring diverse and...
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Regulatory Affairs Associate
2 weeks ago
Bengaluru, India Parexel Full timeAs part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India AliveCor Full time ₹ 12,00,000 - ₹ 24,00,000 per yearAliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and...
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Regulatory Affairs Manager
4 days ago
Bengaluru, Karnataka, India Kumar Organic Products Full timeJob Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...
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Manager - Regulatory Affairs
4 weeks ago
Bengaluru, India Aarna Hr Solutions Full timeJob Description We are seeking a highly experienced and meticulous Manager - Regulatory Affairs to oversee and execute all regulatory activities for drug substances and products. The ideal candidate will be responsible for the preparation, submission, and management of various regulatory documents, ensuring compliance with global regulatory agencies. This...
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Regulatory Affairs
7 days ago
Bengaluru, Karnataka, India MM Staffing & Career Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description:Job SummaryThe Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all...
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Regulatory Affairs Professional
6 days ago
Bengaluru, India Siemens Healthineers Full timeSiemens Healthineers is looking for a Regulatory Affairs Professional for its medical imaging portfolio. **Role/Internal Title**: Regulatory Affairs Professional **Business Title**: Deputy General Manager **Role Summary** - Lead and spearhead the Regulatory compliance requirements of Pre-Conception and Pre-Natal Diagnostic techniques and ensure compliance...
