Regulatory Affairs Sr Mgr (GRAAS Biosimilars)

Regulatory Affairs Sr Mgr (GRAAS Biosimilars)

Group Purpose: To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.

Job Summary:
- Coordination of global regulatory activities relevant to the successful execution and implementation of biosimilar regulatory affairs strategies and plans
- Development of regulatory dossiers and briefing documents required for clinical trials and registration of biosimilar products
- Ensure compliance with regulatory requirements to support ongoing clinical trials
- Ensure compliance with regulatory requirements for licensed products

Key Activities:
Regulatory Strategy and Execution
- Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, MAs, and Responses to Questions for products within the biosimilars portfolio in compliance with approved filing plans, timelines, and regulatory requirements
- Provide regulatory direction on regional regulatory requirements to optimize product development timelines
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning
- Support development and execution of clinical/ non-clinical strategies
- Provide review, input, and regulatory advice into study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports and related regulatory documents used to support product development and registration
- Participate and collaborate with labelling teams on the development of global product labels and core data sheets to align commercial objectives with expected regulatory guidance and precedent
- Collaborate with Amgen affiliates as required to ensure effective implementation of 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 (eg, PMCs and other agency commitments)
Regulatory Intelligence
- Monitor, assess and implement regional 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
- Contribute to appropriate, and participate in, vendor oversight and management for regulatory and safety operations
- Identify process needs to meet internal challenges
- Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function
- Represent Biosimilars Regulatory Affairs on committees, as necessary

Knowledge and Skills
- Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes
- Regulatory experience with product filings
- Ability to understand and communicate scientific and clinical information
- Ability to anticipate and prevent potential issues
- Ability to communicate regulatory strategies and requirements to ensure expectations are understood
- Cultural awareness and sensitivity to achieve results across different regions

Basic Qualifications
- Doctorate degree & 2 years of directly related experience
OR
- Master's degree & 6 years of directly related experience
OR
- Bachelor's degree & 8 years of directly related experience
OR
- Associate's degree & 10 years of directly related experience
OR
- High school diploma / GED & 12 years of directly related experience

Preferred Qualifications
- RAC
- Regulatory knowledge of global regulations
- Regulatory submissions experience
- Working with policies, procedures and SOPs
- Interacting with regulatory agency representatives
- Understanding of drug development