Senior Manager

3 days ago


bangalore, India Biocon Biologics Full time

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.

10+ years experience


Responsible for:

• 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


Key Activities:

Regulatory Strategy and Execution

• 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


Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence


Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function


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


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