Job Description

Department Details
Role Summary
Job Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
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 Responsibilities
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

Educational Qualifications
Required Education Qualification: Bsc
Required Experience: 3 - 8 years