Amgen
biotechnology
EURegulatoryAffairsSeniorManager(Biosimilars)
Neural analysis suggests this role is
optimal for Senior candidates.
“EU Regulatory Affairs Senior Manager (Biosimilars) at Amgen. Skills: EU Regulatory Affairs, Biosimilars regulatory environment, regulatory strategy development and execution, drug life cycle and development process from a regulatory perspective, registration procedures. support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit. detailed development and implementation of European regulatory strategies, submissions, and plans”
What You'll Achieve.
serve patients; achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide; support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit; ensure the regional needs are well defined and implemented; optimize product development; ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning
Industry & Context.
Proactive approach to problem solving
What They're Looking For.
Must Have
Extensive experience of the regional Biosimilars regulatory environment, Proven track record of developing and executing regional Biosimilars regulatory strategy, In-depth understanding of the drug life cycle and development process from a regulatory perspective, In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals, Ability to lead teams and work collaboratively in a dynamic environment, Proactive approach to problem solving, Ability to understand and communicate scientific/clinical information, Ability to anticipate regulatory agency expectations, awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
What You'll Do.
support the regulatory
safety and product development needs of the Amgen Biosimilars Operating Unit
detailed development and implementation of European regulatory strategies
advising the GRT on regional considerations in developing strategy
ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
Plan and manage regulatory submissions for products within Amgen's biosimilar portfolio in compliance with global filing plans and local regulatory requirements
Implement product related regulatory strategies
Regulatory Affairs processes and activity planning
Lead development of regional regulatory documents and meetings in accordance with GRT strategy
Provide regulatory direction on regional regulatory mechanisms to optimize product development
Participate in the development and execution of regional regulatory product strategies
risk management and contingency planning
advise on regulatory implications and requirements related to regional development plans and objectives
Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Ensure and lead regulatory compliance for biosimilar products (eg
Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning
How You'll Work.
Team & Collaboration
work collaboratively in a dynamic environment; collaboration with relevant regional stakeholders; working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products
Communication Scope
Ability to understand and communicate scientific/clinical information; document and communicate outcomes appropriately
Process & Methodology
Plan and manage regulatory submissions, activity planning
Full Job Description
## **Career Category** Regulatory ## ## **Job Description** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. **EU REGULATORY AFFAIRS SENIOR MANAGER - BIOSIMILARS** **LIVE** **What you will do** In this vital role you will work to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of European regulatory strategies, submissions, and plans. Representing the region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders. * Plan and manage regulatory submissions for products within Amgen's biosimilar portfolio in compliance with global filing plans and local regulatory requirements * Implement product related regulatory strategies, Regulatory Affairs processes and activity planning * Lead development of regional regulatory documents and meetings in accordance with GRT strategy * Provide regulatory direction on regional regulatory mechanisms to optimize product development * Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning * Consistent with GRT strategy, advise on regulatory implications and requirements related to regional development plans and objectives * Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately * Ensure and lead regulatory compliance for biosimilar p
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