Associate Manager

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.

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

• Strong attention to detail and compliance focus

• Willingness to learn and grow in CMC regulatory complexity

• Structured, organized, and accountable

• Comfortable working in cross-functional and matrix environments