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 strong expertise in biosimilars and biologics. Proven exposure to United States and European regulatory environments is required. Experience in emerging markets or rest-of-world regulatory frameworks is considered an advantage.
Educational Qualification
Bachelor’s degree or higher in Pharmacy, Biotechnology, Life Sciences, Chemistry, or a related scientific discipline preferred.
Job Overview
The Manager Regulatory Affairs, CMC Biosimilar is responsible for managing regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for biosimilar and biologic products. The role focuses on regulatory submissions, lifecycle management, compliance oversight, and global regulatory strategy development.
This position requires strong expertise in global regulatory frameworks, cross-functional collaboration, and health authority engagement to ensure successful product registrations and regulatory compliance throughout the product lifecycle.
Primary Responsibilities
Product Registrations and Regulatory Submissions
Lead product registration activities by preparing and requesting documentation for complex regulatory filings related to biosimilar products.
Apply project management methodologies to monitor submission activities and meet regulatory timelines.
Prepare regulatory submission packages for routine filings and identify required supporting data.
Collaborate with technical experts to address complex regulatory requirements.
Prepare and submit responses to regulatory deficiency letters.
Cross-Functional Collaboration and Stakeholder Engagement
Represent Regulatory CMC in project meetings and communicate regulatory positions to internal stakeholders.
Monitor regulatory timelines and communicate progress against planned activities.
Identify and escalate risks or issues that may impact project execution.
Affiliate and Regional Coordination
Maintain strong working relationships with regional product leads and affiliate teams.
Ensure regulatory alignment across global and regional functions.
Lifecycle Compliance Management
Assess and approve product change requests and update regulatory documentation accordingly.
Monitor regulatory legislation and industry developments relevant to assigned products.
Ensure ongoing compliance of products with global regulatory requirements.
Regulatory Strategy Development
Develop and implement regulatory CMC strategies for biosimilar and biologic products.
Identify potential regulatory risks and implement mitigation strategies.
Process Improvement and Documentation
Identify opportunities to enhance regulatory processes and operational efficiency.
Support the development of regulatory position papers, work aids, and procedural documentation.
Health Authority Interaction
Participate in regulatory agency meetings and support communications with health authorities.
Licensing and Due Diligence Support
Provide CMC regulatory expertise for licensing reviews and due diligence activities.
Technical and Regulatory Expertise
Maintain knowledge of scientific principles related to biosimilars and biologics.
Develop expertise in global, regional, and country-specific regulatory requirements.
Core Competencies
Adaptability
Effectively prioritize short-term and long-term regulatory activities.
Respond proactively to evolving regulatory requirements and project needs.
Initiative
Anticipate challenges and implement proactive solutions.
Continuously expand knowledge of regulatory and business functions.
Innovation
Apply strategic and innovative approaches to regulatory challenges.
Integrity and Quality Orientation
Deliver high-quality regulatory outputs within established timelines.
Maintain transparency, ethical conduct, and accountability.
Team Collaboration
Work effectively with cross-functional teams to achieve shared objectives.
Leadership Competencies
Define and communicate regulatory CMC strategies and ensure stakeholder alignment.
Mentor junior team members and provide subject matter guidance.
Drive performance and support organizational objectives.
Facilitate effective decision-making through collaboration.
Promote an open environment that encourages knowledge sharing and feedback.
Career Opportunity
This role offers an opportunity to contribute to global biosimilar product development and regulatory strategy within the pharmaceutical and biotechnology sector. The position provides exposure to international regulatory frameworks, strategic regulatory planning, and lifecycle management for innovative biologic therapies.
Uttar Pradesh :
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Siliguri |Illinois :
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