Manager Regulatory Affairs, CMC Biosimilar
Job Location
Mumbai, India
Job Category
Regulatory Affairs
Employment Type
Full-Time
Experience Required
Minimum 10 years of experience in Global Regulatory Affairs with a strong focus on biosimilars and biologics. Proven exposure to United States and European regulatory environments is required. Experience working with emerging markets or rest-of-world regulatory frameworks is an added advantage.
Educational Qualification
Bachelor’s or advanced degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related scientific discipline preferred.
Job Overview
The Manager Regulatory Affairs, CMC Biosimilar is responsible for leading regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for biosimilar and biologics products. The role focuses on regulatory submissions, lifecycle management, global compliance, and regulatory strategy development while ensuring adherence to international regulatory standards.
This position requires strong expertise in biosimilar regulatory frameworks, cross-functional collaboration, health authority engagement, and global product registration processes. The role supports regulatory compliance throughout the product lifecycle and contributes to strategic regulatory decision-making.
Primary Responsibilities
Product Registrations and Regulatory Submissions
Lead product registration activities by preparing and requesting documentation for complex regulatory filings related to biosimilar products.
Manage regulatory submission timelines using structured project management approaches.
Prepare registration packages for routine filings and identify required supporting data.
Collaborate with technical experts to address complex regulatory requirements.
Prepare and submit responses to deficiency letters from regulatory authorities.
Cross-Functional Collaboration and Stakeholder Management
Represent Regulatory CMC in project meetings and communicate regulatory positions to stakeholders.
Monitor regulatory activities against planned timelines and provide progress updates.
Identify and escalate risks or issues impacting regulatory project progression.
Affiliate and Regional Coordination
Maintain strong working relationships with regional product leads and affiliate teams.
Ensure alignment of regulatory activities across global and regional stakeholders.
Lifecycle Compliance Management
Assess and approve product change requests and maintain regulatory documentation.
Monitor evolving regulatory legislation and industry developments.
Ensure continuous product compliance with global regulatory requirements.
Regulatory Strategy Development
Develop and implement regulatory CMC strategies for biosimilar and biologics products.
Identify regulatory risks and implement mitigation strategies aligned with business objectives.
Process Improvement and Documentation
Identify opportunities to improve regulatory processes and operational efficiency.
Support development of regulatory position papers, work aids, and procedural documentation.
Health Authority Interaction
Participate in regulatory agency meetings and support regulatory communications.
Licensing and Due Diligence Support
Provide CMC regulatory expertise for licensing reviews and due diligence activities.
Technical and Regulatory Expertise
Maintain knowledge of scientific and technical principles relevant to biosimilars and biologics.
Develop expertise in global, regional, and country-specific regulatory frameworks.
Core Competencies
Adaptability
Effectively prioritize short-term and long-term regulatory tasks.
Respond quickly to changing regulatory requirements and project needs.
Initiative
Proactively identify challenges and implement solutions.
Continuously expand knowledge of regulatory and business processes.
Innovation
Apply creative and strategic thinking to address regulatory challenges.
Integrity and Quality Focus
Deliver high-quality regulatory outputs within defined timelines.
Maintain ethical conduct, transparency, and accountability.
Team Collaboration
Work collaboratively with cross-functional teams to achieve shared goals.
Leadership Competencies
Define and communicate regulatory CMC strategies and obtain stakeholder alignment.
Mentor and support junior team members through knowledge sharing and training.
Drive performance and encourage goal achievement across teams.
Support effective decision-making through cross-functional collaboration.
Promote open communication and knowledge sharing across the organization.
Career Opportunity
This role offers an opportunity to contribute to global biosimilar development, regulatory strategy, and lifecycle management within the pharmaceutical and biotechnology industry. The position provides exposure to international regulatory environments, global health authority interactions, and strategic regulatory leadership in biosimilar product development.
Uttar Pradesh :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Washington |Delaware :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
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Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
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