Manager Global Regulatory Affairs
3 weeks ago
Manager – Global Regulatory Affairs
Location – Head-Office, Bangalore, IN
BIOCON BIOLOGICS
Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.
Job Summary:
- Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
- Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
- Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
- Collaboration with partners to develop and execute global regulatory activities
- Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
- Provide regulatory direction on global regulatory requirements to support product development
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
- Support development and execution of clinical/non-clinical strategies
- Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
- Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
- With minimal supervision, participate in development of risk management and contingency planning
- Ensure and lead regulatory compliance for biosimilar products
- Participation in regulatory meetings with Health Authorities
Knowledge and Skills:
- Comprehensive understanding of Regulatory activities
- Regulatory experience with product filings
- Team skills, especially in working with internal and external partners
- Familiarity with project management requirements
- Ability to understand and communicate scientific CMC information
- Anticipate and prevent potential issues
- Ability to communicate regulatory strategies and requirements to ensure expectations are understood
Education/Qualification:
- B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc
- A min of 5 years of experience in global regulatory affairs
- Preference for folks who has global RA experience in advanced markets
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