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Senior Regulatory Affairs Manager

1 month ago

WottonunderEdge, Gloucestershire, United Kingdom https:www.energyjobline.comsitemap Full time
Senior Regulatory Affairs Manager

Cambridge (Home working with some travels to Cambridge when needed)

We are seeking a highly experienced Senior Regulatory Affairs Manager to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The successful candidate will be responsible for building and maintaining a strong collaborative partnership with product teams, especially with team members from Tech Ops and Quality. They will act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors. They will also lead a team of permanent employees (CMC regulatory) and supervise contractors and consultants supporting the CMC regulatory objectives and deliverables.

Key Responsibilities:

  • Ensure that RA CMC strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate product team decision making.
  • Responsible for RA CMC focused agency negotiations and interactions, including scientific advice.
  • Lead a team of permanent employees within CMC regulatory.
  • Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio.

Requirements
  • Scientific based degree
  • Proven pharmaceutical experience in regulatory or technical CMC
  • Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners.

Flexible Benefits Package

We offer a competitive salary and a range of benefits to support your well-being and career development.


Diversity and Inclusion

We are committed to building an inclusive environment where people can thrive, grow and achieve their full potential.


If you're interested in this role, please submit your application.