Associate Manager

Biocon Biologics; Bengaluru; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Biocon Biologics in Bengaluru, India, seeks an Associate Manager/Manager in Regulatory Affairs (CMC – Drug Substance) to lead regulatory content development and lifecycle management for biologics DS.

You will collaborate with Process Development, QA, Manufacturing and Analytical teams to prepare CTD Module 3.2.S, variations, and regulatory responses; ensure compliance with ICH/Q-series; and support DS tech transfer.

Qualifications

• Master’s degree required in a relevant discipline.
• Ability to interpret scientific data and translate it into regulatory documentation.
• Strong written communication and document-management skills.

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/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.

Education

Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related discipline

Job description

Job Title Associate Manager/ Manager – Regulatory Affairs (CMC – Drug Substance)

Function Global Regulatory Affairs – CMC

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.

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: o INDs / IMPDs o BLAs / MAAs o 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.
• 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: o Process development summaries o Scale-down model qualification data o Process characterisation studies o Process validation o Hold time studies o Resin re-use and lifecycle studies o viral clearance studies

Qualifications & Experience Education

• Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related discipline.

Knowledge & Skills

• Basic to working knowledge of: o Drug Substance manufacturing processes o Process development and characterisation concepts o PPQ and validation principles o Viral clearance and viral safety requirements
• 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 Behavioral Competencies
• Structured, organized, and accountable
• Comfortable working in cross-functional and matrix environments