MSc Biotechnology Jobs at Biocon | Candidates Apply Now
Are you looking for MSc Biotechnology Jobs, Biocon Jobs, or high-growth Regulatory Affairs Jobs in India? We are hiring a Regulatory Affairs Manager in Bengaluru, Karnataka. This exciting opportunity is ideal for biotechnology, biochemistry, pharmacy, and chemical engineering candidates who want to build a strong career in biologics, biosimilars, CMC regulatory affairs, and global regulatory submissions.
About the Company
Biocon Biologics is a leading global biopharmaceutical company focused on developing affordable biosimilars and biologic therapies. The company is recognized for innovation in biotechnology, research-driven healthcare solutions, and global regulatory excellence. Biocon Biologics offers outstanding career opportunities for candidates seeking Biocon Jobs, MSc Biotechnology Jobs, and advanced Regulatory Affairs Jobs in India’s growing biotech sector.
Key Responsibilities
- Support preparation and review of Drug Substance manufacturing process descriptions for global regulatory submissions (CTD Module 3.2.S).
- Assist in the preparation of variation and 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.
- Work closely with Process Development, MSAT, QA, Manufacturing, and Analytical teams to gather regulatory inputs.
- Help maintain consistency of regulatory positions across regions.
- Assist senior team members in assessing data adequacy for regulatory submissions and post-approval changes.
- Support responses to health authority queries related to DS manufacturing processes.
- Support regulatory review of process development summaries, scale-down model qualification data, process characterization studies, process validation, hold time studies, resin re-use and lifecycle studies, and viral clearance studies.
Qualifications
Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related discipline.
This role is highly suitable for candidates searching for MSc Biotechnology Jobs and specialized Regulatory Affairs Jobs in the pharmaceutical and biotechnology industry.
Experience & Knowledge Required
- Basic to working knowledge of Drug Substance manufacturing processes.
- Understanding of process development and characterization concepts.
- Knowledge of PPQ and validation principles.
- Familiarity with viral clearance and viral safety requirements.
- Familiarity with ICH guidelines including Q5E, Q7, Q8, Q9, Q10, and Q11.
Skills Needed
- 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.
- Structured, organized, and accountable work approach.
- Comfortable working in cross-functional and matrix environments.
- Willingness to learn and grow in CMC regulatory complexity.
Candidates searching for MSc Biotechnology Jobs, Biocon Jobs, and Regulatory Affairs Jobs should not miss this excellent opportunity at Biocon Biologics in Bengaluru. Apply now to build a strong career in biologics, biosimilars, and global regulatory affairs.
