Senior Regulatory Affairs Manager

My client are seeking a Senior Regulatory Manager to join them in either the General Medicine or Oncology Regulatory team, part of the Global Regulatory Affairs function in Europe. This team are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.

Role Responsibilities:

To acquire and maintain all the required licenses to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.

You will support one or more products from a regional regulatory perspective, within either Oncology or General Medicine, depending on your expertise and interest.

• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's 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 (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
• 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 global clinical development plans and objectives
• Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately

Key Requirements:

• Degree educated in a scientific discipline
• Extensive experience in regional regulatory environment
• Proven track record of developing and executing regional 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
• Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

This role will be majority work-from-home, with weekly trips to the Uxbridge or Cambridge offices required.

In return for your work, my client offer growth opportunities to learn and move up in a global organization, working in a diverse and inclusive community of belonging. They offer a generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.