Associate Manager

Biocon Biologics Limited; Bengaluru; On-site; INR 1,600,000 - 2,300,000; Full time

Job summary

Biocon Biologics Limited is seeking an Associate Manager/Manager for Regulatory Affairs (CMC – Drug Substance) to support development, registration, and lifecycle management of CMC activities for biologics/biosimilars. You will collaborate with Process Development, QA, Manufacturing, and Analytical teams to prepare, review, and maintain regulatory content in CTD format while ensuring regulatory compliance.

The role requires a Master’s degree and familiarity with ICH guidelines, DS manufacturing

Qualifications

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

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
• 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 characterisation studies, Process validation, Hold time studies, Resin re-use and lifecycle studies, viral clearance studies

Skills

Drug Substance manufacturing

Process development

Characterisation concepts

PPQ & validation

Viral clearance

Viral safety

ICH guidelines

Education

Master’s degree

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:
  • 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
• 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 characterisation studies
  • Process validation
  • Hold time studies
  • Resin re-use and lifecycle studies
  • 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:
  • Drug Substance manufacturing processes
  • Process development and characterisation concepts
  • PPQ and validation principles
  • 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