Regulatory Affairs Jobs at Biocon | Associate Manager Role
An exciting opportunity is available for professionals looking for Associate Manager Jobs in Regulatory Affairs at Biocon. Based in Bangalore, this role focuses on Chemistry, Manufacturing and Controls (CMC) activities for biologics and biosimilars, supporting global regulatory submissions and lifecycle management. Candidates with backgrounds in Biotechnology, Pharmacy, Chemistry, or Chemical Engineering are encouraged to apply
About Biocon
Biocon is one of India’s leading biopharmaceutical companies, dedicated to developing innovative and affordable healthcare solutions worldwide. Headquartered in Bangalore, Biocon specializes in biologics, biosimilars, and complex pharmaceuticals while maintaining a strong global regulatory presence. The company provides excellent career opportunities for professionals seeking growth in Regulatory Affairs, CMC, and pharmaceutical development.
- Job Title: Associate Manager/Manager – Regulatory Affairs (CMC – Drug Substance)
- Function: Global Regulatory Affairs – CMC
- Location: Bangalore, India
Job Description
The Associate Manager will play a crucial role in supporting the preparation and review of Drug Substance manufacturing process descriptions for global regulatory submissions. This position involves assisting in the preparation of variation and supplement documentation associated with drug substance tech transfer activities. The incumbent will also ensure that all documents comply with the CTD format, regulatory guidance, and internal
quality standards, thereby facilitating the smooth progression of regulatory affairs jobs in Bangalore.Key Responsibilities
- Support preparation and review of Drug Substance manufacturing process descriptions for global regulatory submissions (CTD Module 3.2.S).
- Assist in preparation of variation/supplement documentation associated with DS tech transfer activities.
- Support preparation, review, compilation, and publishing of CMC sections for INDs / IMPDs, BLAs / MAAs, and Variations / Supplements.
- Maintain regulatory trackers for DS-related submissions, commitments, and agency interactions.
- Ensure documents comply with CTD format, regulatory guidance, and internal quality standards.
- Assist in ensuring consistency of DS process descriptions across development stages and markets.
- Work closely with Process Development, MSAT, QA, Manufacturing, and Analytical teams to gather regulatory inputs.
- Support responses to health authority queries related to DS manufacturing processes.
Eligibility Criteria
- Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related discipline.
Required Skills
- Basic to working knowledge of Drug Substance manufacturing processes and process development concepts.
- Familiarity with ICH guidelines (Q5E, Q7, Q8, Q9, Q10, Q11).
- Ability to interpret scientific data and translate it into regulatory documentation.
- Strong written communication and document-management skills.
- Good coordination and stakeholder-management abilities.
- Strong attention to detail and compliance focus.
- Willingness to learn and grow in CMC regulatory complexity.
- Comfortable working in cross-functional and matrix environments.
Biocon offers professionals the opportunity to work on global regulatory projects involving biologics and biosimilars while collaborating with experienced cross-functional teams. Employees gain exposure to international regulatory submissions, advanced pharmaceutical development, and continuous learning opportunities, making Biocon an excellent choice for professionals seeking Associate Manager Jobs in Regulatory Affairs.
Rasayanika is a career information portal and is not the recruiter for this position. All details are sourced from the official notification. Candidates should verify eligibility and deadlines on the official website before applying.
