Manager – Regulatory Affairs, CMC Biosimilar
Location: Mumbai, Maharashtra, India
Function: Regulatory Affairs – CMC (Biosimilars & Biologics)
Employment Type: Full-Time
Company Overview
Abbott Laboratories is a global healthcare leader committed to advancing innovative therapies through strong scientific, regulatory, and compliance frameworks. In India, Abbott plays a strategic role in delivering high-quality biologics and biosimilar products supported by global regulatory excellence.
Role Overview
The Manager – Regulatory Affairs, CMC Biosimilar is responsible for leading Chemistry, Manufacturing & Controls (CMC) regulatory strategies and submissions for biosimilar and biologic products. This role requires deep expertise in global regulatory frameworks, including US and EU biosimilar pathways, along with strong cross-functional leadership and lifecycle compliance management.
This opportunity is ideal for senior regulatory professionals seeking Biosimilar Regulatory Affairs Manager jobs in Mumbai within a global pharmaceutical organization.
Key Responsibilities
1. Product Registrations & Global Submissions
Lead preparation and submission of complex CMC dossiers for biosimilar and biologic products.
Compile and review documentation required for global regulatory filings.
Prepare and manage responses to regulatory deficiency letters and agency queries.
Apply structured project management practices to ensure adherence to global submission timelines.
Seek expert scientific input where required for complex filings.
2. Regulatory Strategy & Risk Management
Develop and execute Regulatory CMC strategies for assigned biosimilar/biologic portfolios.
Identify regulatory risks and implement mitigation plans aligned with business goals.
Represent Regulatory CMC at project meetings and communicate agreed regulatory positions.
3. Cross-Functional & Affiliate Collaboration
Partner closely with Global Regulatory, Quality, Manufacturing, R&D, and Supply Chain teams.
Maintain strong coordination with Regional Product Leads and affiliate colleagues.
Monitor planned versus actual regulatory milestones and proactively communicate deviations.
4. Lifecycle Compliance Management
Assess and approve change control submissions to ensure continued product compliance.
Maintain awareness of evolving regulatory legislation in the US, EU, and emerging markets.
Ensure products remain compliant throughout their lifecycle.
5. Health Authority Interaction & Licensing
Participate in Health Agency meetings and regulatory consultations as required.
Provide CMC regulatory support during due diligence and licensing reviews.
6. Process Excellence & Governance
Identify operational improvement opportunities within Regulatory CMC processes.
Contribute to development of position papers, guidance documents, and internal work aids.
7. Technical Expertise
Demonstrate in-depth understanding of CMC principles for biologics and biosimilars.
Maintain strong knowledge of global regulatory guidelines, including US FDA and EMA frameworks.
Apply specialized regulatory knowledge for assigned country and product-class requirements.
Core Competencies
Adaptability & Prioritization
Effectively manage short-term and long-term regulatory deliverables.
Re-prioritize activities based on evolving regulatory or business requirements.
Initiative & Innovation
Proactively identify risks and implement preventive solutions.
Demonstrate an intrapreneurial mindset to enhance regulatory processes.
Integrity & Compliance Focus
Deliver high-quality, accurate regulatory submissions.
Uphold transparency, ethical standards, and compliance at all times.
Collaboration & Teamwork
Actively engage cross-functional teams to achieve shared regulatory objectives.
Leadership Competencies
Strategic Vision
Clearly articulate and align Regulatory CMC strategies with business priorities.
Talent Development
Mentor junior team members and provide subject matter training.
Strengthen leadership capabilities through continuous development.
Results Orientation & Decision-Making
Drive timely execution of regulatory commitments.
Support data-driven and compliant decision-making processes.
Open Communication & Knowledge Sharing
Provide constructive feedback and foster transparent discussions.
Encourage collaborative learning across regulatory teams.
Educational Qualifications
Bachelor’s Degree in Pharmacy, Biotechnology, Biology, Chemistry, Pharmacology, or related Life Sciences discipline.
Advanced degree preferred.
Experience Required
Minimum 10 years of experience in Global Regulatory Affairs for Biosimilars or Biologics.
Proven hands-on exposure to US FDA and EMA regulatory submissions.
Experience in emerging markets and Rest of World (ROW) regulatory environments is an added advantage.
Strong expertise in CMC documentation for biologics and biosimilars.
Why Join Abbott?
Lead global CMC strategies for high-impact biosimilar portfolios.
Engage directly with international regulatory authorities including US and EU agencies.
Opportunity to shape regulatory excellence within a globally recognized healthcare organization.
SEO & GEO Keywords: Manager Regulatory Affairs CMC Biosimilar Mumbai, Biosimilar Regulatory Jobs India, Global Regulatory Affairs Biosimilars US EU, CMC Regulatory Manager Mumbai, Biologics Regulatory Affairs Jobs India, Abbott Regulatory Affairs Careers Mumbai.
This role is suited for experienced biosimilar regulatory professionals seeking Manager – Regulatory Affairs CMC positions in Mumbai with strong global exposure to US, EU, and emerging market regulatory frameworks within a leading pharmaceutical organization.
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