Regulatory Affairs Jobs at Biocon Biologics
Looking to build a rewarding career in global regulatory affairs? Here’s an exciting Regulatory Affairs Job opportunity with Biocon Biologics. Biocon Biologics is hiring an Associate Manager/Manager – Regulatory Affairs (CMC – Drug Substance) in Bengaluru for candidates with a Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related disciplines. If you have a passion for biologics, biosimilars, CMC documentation, and global regulatory submissions, this could be the career move you’ve been waiting for.
About Biocon Biologics
Biocon Biologics is a leading global biopharmaceutical company based in India, specialising in the development and manufacturing of biologics and biosimilars. The organisation is committed to improving healthcare access and affordability through innovative solutions and is a significant player in the biotechnology industry. With a strong focus on regulatory compliance, Biocon Biologics plays a crucial role in advancing healthcare through its regulatory affairs jobs.
Job Details
- Job Title: Associate Manager/Manager – Regulatory Affairs (CMC – Drug Substance)
- Function: Global Regulatory Affairs – CMC
- Location: Bangalore, India
Role Purpose
The role supports development, registration, and lifecycle management of CMC activities for biologics/biosimilars. The incumbent will work closely with senior regulatory colleagues and cross-functional teams to support preparation, review, and maintenance of CMC regulatory content, ensuring compliance with global regulatory expectations.
Job Description
The Associate Manager in regulatory affairs jobs at Biocon Biologics will be responsible for supporting the preparation and review of Drug Substance manufacturing process descriptions for global regulatory submissions. This includes assisting in the preparation of variation/supplement documentation associated with DS tech transfer activities and ensuring compliance with regulatory standards. The position requires collaboration with various teams, including Process Development, MSAT, QA, Manufacturing, and Analytical teams, to gather regulatory inputs and maintain consistency across development stages and markets.
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, Variations, and 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.
- Help maintain consistency of regulatory positions across regions.
- Support responses to health authority queries related to DS manufacturing processes.
Eligibility Criteria
Candidates must possess a Master’s degree in Biotechnology, Biochemistry, or a 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.
Why Join?
Biocon Biologics offers a unique opportunity for professionals in regulatory affairs jobs to contribute to significant advancements in the biotechnology sector. The organization fosters a collaborative environment that encourages learning and growth, making it an ideal place for those looking to excel in their careers.
Summary
The regulatory affairs jobs at Biocon Biologics present an excellent opportunity for candidates with a strong background in biotechnology and regulatory compliance. With a focus on CMC activities for biologics and biosimilars, this role is crucial for those pursuing a career in regulatory affairs. Qualified candidates are encouraged to apply at the earliest to seize this opportunity.
