Manager, Regulatory LCM CMC-3

Overview

Project-facing CMC regulatory role supporting life-cycle management of post-approval filings and change control for biologics.

What you'll do

• Prepare, review, and submit post-approval CMC regulatory filings, including Variations (Type IA/IB/II), Supplements (PAS, CBE-30, CBE-0), and annual reports and renewals.
• Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities).
• Track submission timelines and ensure on-time delivery.
• Evaluate CMC changes (manufacturing, analytical, raw materials, etc.) for regulatory impact.
• Support regulatory classification and filing strategy for change controls.
• Work closely with cross-functional teams to ensure appropriate documentation.
• Maintain and update Module 3 (CMC) sections of regulatory dossiers.
• Support product lifecycle activities including CMC-related label updates, site transfers, and process improvements.
• Ensure compliance of existing licenses with updated regulatory requirements.
• Support preparation of responses to queries, deficiency letters, and information requests.
• Assist in compiling documentation for regulatory inspections and audits.
• Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations teams.
• Participate in change control meetings and provide regulatory input.
• Communicate regulatory requirements clearly to stakeholders.

What you'll need

• PhD with 1 to 3 years, MS with 4 to 6 years, or BS with 6 to 8 years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent.
• Subject matter expertise in regulatory affairs and related activities.
• Previous experience in life cycle management activities with direct experience in variation filing for US and EU.
• Ability to work in a matrix, teams, and diverse cultures is essential.
• Fluency in English is essential.
• Understanding of regional frameworks: US FDA (BLA lifecycle, supplements categories), EU EMA (Variation Regulation), and Japan PMDA requirements.
• Knowledge of biologics manufacturing processes: cell culture, upstream/downstream processing, aseptic filling, and sterility assurance.
• Understanding of analytical methods and specifications, and process validation and control strategies.
• Familiarity with ICH guidelines (Q5E, Q6B, Q8–Q12).
• Understanding of supply chain implications of regulatory decisions.

Nice to have

• Other languages are beneficial.

Details

• Location: India Home Office.