Senior Manager, Global Regulatory Affairs Biosimilars

Thousand Oaks, CA, US
Nov 08, 2020
Required Education
High School or equivalent
Position Type
Full time
Title (Role): Regulatory Affairs Sr Mgr (Biosimilars)

Organization: Global CMC, Device, & Biosimilar Regulatory Affairs, and Business Operations

Team: 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:

Accountable for the development and execution of regulatory strategies, plans, and marketing applications for biosimilar products.

Responsible for:
• Development and Implementation of regulatory strategies in support of global registrations for products within the biosimilars portfolio
• Coordination of activities and deliverables provided by other GRAAS and Amgen functions to support the development, approval, and long-term planning of biosimilar products
• Collaboration with Amgen partners to develop and execute regional regulatory activities

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
• Manage the development of global product labels and core data sheets to align commercial objectives with expected regulatory guidance and precedent
• Collaborate with partners and Amgen 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 (eg, PMCs and other agency commitments)
• Participation in regulatory meetings with Health Authorities

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

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Contribute to appropriate, and participate in, partner and 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
• Team skills, especially in working with internal and external regulatory teams
• Strong familiarity with project management requirements
• 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

• Planning and organizing abilities
• Managing multiple activities
• Team work
• Problem solving abilities
• Multi-disciplinary nature
• Dealing with ambiguity
• Action oriented
• Self-starter
• Conflict management
• Strong oral and written communication skills
• Negotiation, collaboration and leadership skills
• Excellent interpersonal, organizational, supervisory skills
• Ability to provide direction and support for team members

Education & Experience (Basic)

Doctorate degree and 2 years of directly related experience
Master's degree and 6 years of directly related experience
Bachelor's degree and 8 years of directly related experience
Associate's degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience

Education & Experience (Preferred):

• Regulatory knowledge of global regulations
• Regulatory submissions experience
• Understanding of drug development
• Previous interaction with regulatory agency representatives

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.