Regulatory Affairs Specialist

Job Summary :

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

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
• DMF preparations, review of changes and routine updates to Global Regulatory Agencies
• Dossier preparations of Biosimilar biologics for ICH regions 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

Education

Doctorate degree OR Master's degree