Vice President, International Regulatory Affairs

Vice President, International Regulatory Affairs

Alnylam Pharmaceuticals

Maidenhead, United Kingdom

Overview

Reporting to the Senior Vice President, Head of Global Regulatory Affairs, the Vice President (VP) of International Regulatory Affairs will be a leader and key member of the Global Regulatory Team and will be responsible for developing and implementing strategy and planning for global regulatory in territories beyond the US.

The VP will be responsible for hiring individuals to support establishment of the International regulatory team commensurate with company P5 x 25 goals and strategic priorities. In collaboration with their direct reports, the VP will identify the key strategic regulatory drivers for successful initial filings and for label expansions, supplemental applications/variations in markets beyond the US. The VP will ensure that product development strategies reflect the latest health authority requirements and thinking and enable adoption of novel regulatory approaches, as appropriate. This role will be required to present and defend regulatory global expansion plans to Senior Management.

The role will be based in Maidenhead, UK.

Summary of Key Responsibilities

  • Recruiting and mentoring staff globally
  • Setting priorities
  • Applying critical thought in product development and implementing to drive innovation
  • Identifying, assessing, and mitigating risks
  • Understanding business imperatives including market-related drivers
  • Interfacing with health authorities
  • Keeping up with global regulatory requirements and guidance; and providing oversight and review of key regulatory documents and applications

Qualifications

  • Proven track record of operating at a senior leadership level in the pharmaceutical industry
  • Deep knowledge and understanding of regulatory requirements and environment, with in depth understanding of European regulatory procedures
  • Strong scientific background and understanding; PhD degree in Life/Health Sciences preferred
  • Able to drive strategic thinking of crossfunctional teams and plans for successful regulatory outcomes
  • Dynamic individual with excellent written and communication skills
  • Ability to skilfully and appropriately manage, develop and mentor individuals
  • Ability to set priorities, work independently and deliver in a timely manner
  • Experience with CTA and MAA submissions
  • Experience in interfacing with regulatory authorities
  • Strong organizational skills
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel in a matrix environment
  • Attention to detail is essential

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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