Manager, Regulatory LCM CMC

This is a fully remote position, open to applicants in India.

📋 Description

• Prepare, review, and submit post-approval CMC regulatory filings, which include Type IA/IB/II variations, PAS, CBE-30, CBE-0 supplements, annual reports, and renewals.

• Ensure that submissions comply with the regional requirements set by the FDA, EMA, and other global health authorities.

• Monitor submission timelines and guarantee timely delivery.

• Assess CMC changes related to manufacturing, analytical methods, raw materials, and other areas for their regulatory impact.

• Aid in the regulatory classification and filing strategy for change controls.

• Collaborate with cross-functional teams to ensure the necessary documentation is in place.

• Maintain and update Module 3 CMC sections of regulatory dossiers.

• Support lifecycle activities, including CMC-related label updates, site transfers, and process enhancements.

• Ensure compliance of existing licenses with updated regulatory requirements.

• Assist in preparing responses to queries, deficiency letters, and information requests.

• Help compile documentation for regulatory inspections and audits.

• Work together with Quality, Manufacturing, Supply Chain, and Technical Operations teams.

• Participate in change control meetings and provide regulatory insights.

• Clearly communicate regulatory requirements to stakeholders.

⛳️ Requirements

• PhD with 1–3 years of relevant experience, MS with 4–6 years, or BS with 6–8 years in pertinent roles within the Pharmaceutical/Biotechnology Industry, or equivalent.

• Expertise in regulatory affairs and associated activities.

• Previous involvement in life cycle management activities, specifically with variation filing for the US and EU.

• Familiarity with the US FDA BLA lifecycle and supplements categories.

• Knowledge of EU EMA Variation Regulation.

• Understanding of Japan PMDA requirements.

• Awareness of biologics manufacturing processes, including cell culture and upstream/downstream processing.

• Knowledge of aseptic filling and sterility assurance procedures.

• Understanding of analytical methods and specifications.

• Familiarity with process validation and control strategies.

• Knowledge of ICH guidelines (Q5E, Q6B, Q8–Q12).

• Comprehension of supply chain implications stemming from regulatory decisions.

• Ability to operate within a matrix environment, collaborate in teams, and engage with diverse cultures.

• Proficiency in English; proficiency in other languages is an asset.

🏝️ Benefits

• Fully remote work arrangement.