Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager

Location Brentford

Contract Temporary

Reference TKSenreg

Date Posted

Consultant

Apply now

1 week left to apply


Regulatory Affairs Senior Manager

This is a great opportunity for an experienced regulatory professional to work with a global pharmaceutical leader. The purpose of this role is to provide regulatory leadership, governance and expertise to one of their leading brands, ensuring that products are successfully introduced or maintained globally. Using your experience of global regulatory affairs, you will build a network of collaborative relationships within the sub-category and LOC/Region and ensure all regulatory requirements are met for both innovation and existing products according to company values.

Some main aspects of the role include:

  • Act as a Business Partner and provide regulatory advice across sub-Category/significant portfolio on all aspects of drug development and regulatory requirements, both current and future.
  • Provide regulatory path to market/claims for a one of the leading brands.
  • Develop novel regulatory strategies and influences approaches in order to secure competitive approvals and speed to market in conjunction with regulatory teams.
  • Communicate, influence and negotiate effectively with cross-functional internal and external groups at all levels.
  • Ensure appropriate prioritization and resourcing of projects and delivery of high-quality regulatory files to agreed timelines.
  • Lead non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to competitive advantage.
  • Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines.
  • Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the CAP meetings and tools.
  • In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.

Overall this is a challenging and rewarding role that is crucial to the delivery of a successful regulatory strategy. If this sounds like the opportunity for you, apply now, and feel free to contact Tom Kirkpatrick for more information.

Offered on an initial 12 month contract, this falls within IR35.

 


Regulatory Affairs Senior Manager

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