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Senior Manager EU Regulatory Affairs

Cambridge
80,000
Permanent
Regulatory Affairs

Compass Life Sciences have partnered with a global large biotech that specialise in a range of advanced and cutting edge therapy areas, including an exciting pipeline within Oncology. Due to a hugely successful 18 months, they have secured investment to build their expertise within EU Regulatory Affairs, for which they are looking to recruit a number of experienced Regulatory Affairs professionals for this expanding team.

More Info

Compass Life Sciences have partnered with a global large biotech that specialise in a range of advanced and cutting edge therapy areas, including an exciting pipeline within Oncology. Due to a hugely successful 18 months, they have secured investment to build their expertise within EU Regulatory Affairs, for which they are looking to recruit a number of experienced Regulatory Affairs professionals for this expanding team.

The Role

The Senior Manager level role within the EU Regulatory Affairs team is focused on acquisition and maintenance of required licenses so to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. As a representative of the region, this position is responsible for advising the global regulatory team on regional and local considerations relating to the development of strategies, so to ensure that these are defined and implemented in collaboration with other regional stakeholders.

Key areas of responsibility will also include;

  • Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the company'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 global 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 (PIP))
  • Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Consistent with global 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

Requirements

To be considered for this role, our client is looking for candidates that are able to demonstrate the following experiences and track record;

  • 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

If you are interested in learning more, please contact me directly today as our client are looking to appoint as soon as possible. For further information please contract me at [email protected], or phone +44 (0)7738 586 627

Recommendations

Compass Associates Ltd. trading as Compass Life Sciences are acting as a Recruitment Consultancy for this permanent vacancy; we offer £250 worth of John Lewis Vouchers for each successful recommendation.

Apply for the position of Senior Manager EU Regulatory Affairs now with Compass Life Sciences

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