Director Regulatory Affairs ; Oncology


Director Regulator Affairs; Oncology - Japanese Pharma - Hertfordshire (Home Based Role)
Ideal Transitional Role for a Regulatory Senior Manager or Associate Director looking to take a step up into a leadership role with strategic oversight.

Job Description
Reporting to a UK based Senior Director - the Director Regulatory Affairs; Oncology will for key assigned compounds, represent regulatory strategy as the Global Regulatory Lead as well as providing regulatory strategy and submission support to help drive the full drug development process.

The successful candidate will network and interact effectively with key regulatory agencies.



Key Responsibilities



  • Focus on driving forward the clinical development process for key compounds assigned, by ensuring the timely submission of all clinical trial for New Active Substances (NASs), contributing to clinical development plans and providing advice on regulatory clinical trial requirements to the International Project Teams (IPTs).

  • Lead major MAA submissions and negotiate with Health Authorities for the approval of products with optimal labelling.

  • Maximise product lifecycle management and licence maintenance for Eisai's current marketed products.

  • Provide direction and advice to immediate subordinates and other members of the Regulatory Affairs department as appropriate.




Personal Specification



  • A good knowledge of the global regulatory environment.

  • Ability to direct Regulatory Strategy and contribute to its outcome within area of responsibility.

  • Strong EU regulatory experience and a good understanding of US regulatory processes.

  • Experience of both early and late phase drug development process and working with international project teams.

  • Desirable to have previous experience in the oncology therapeutic area.

  • Experience of providing strategic input into regulatory documentation and integrated global development plans.

  • Good experience of working with regulatory agencies, including leading agency scientific advice and pre-submission meetings/discussions and writing agency briefing documents.

  • Extensive submission experience (MAAs, CTAs, scientific advice requests, PIPs, OMPD applications etc).

  • Experience in managing a team and able to assume accountability for the team with clear project goals/objectives.



Apply - Submit
If you are interested in this opportunity then please send your CV and/or Cover Letter to paul@blackfieldassociates.com or call Paul Shaw on +442392 322354.



STR Limited is acting as an Employment Agency in relation to this vacancy.




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