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Manager Global Regulatory Affairs

3 months ago

Bengaluru, India Biocon Biologics Full time

Manager - Global Regulatory Affairs

Bangalore, India


Job Summary:

Accountable for global CMC regulatory strategies with focus on analytical aspects for developmental/marketing submissions and Life Cycle Management for biosimilar products.


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

•Ability to communicate regulatory strategies and requirements to ensure expectations are understood• Team skills, especially in working with internal and external partners

• Familiarity with project management requirements


Knowledge and Skills

• Comprehensive understanding of regulatory activities

• In depth knowledge of analytical aspects of biosimilar development, protein characterization and analytical testing

• Hands on experience of method development, qualification/validation, sample analysis

• Ability to give critical inputs on study design for process change, method change, stability studies, bridging studies, outsourced studies etc as per relevant ICH guidelines

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues