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Senior Regulatory Affairs Executive

Rutherford Briant
Job LocationBasildon
EducationNot Mentioned
Salary£40,000 - £50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Rutherford Briant are recruiting for a Regulatory Manager based in Basildon.The role is for an exciting, fast-growing pharmaceutical business. This is a newly created position due to the ongoing growth of the business. Duties include:

  • Providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
  • Leading the preparation of core dossiers and submissions for global roll out.
  • Authors, reviews and approves M3 dossier sections as necessary, justification documents and Product Information.
  • In collaboration with global partners, consultancies and distributors, outlines global regulatory intelligence and form a global regulatory strategy.
  • In collaboration with senior management and project strategy teams, develops and reviews global cross functional regulatory strategies.
  • Negotiates and makes agreements on behalf of the department.
  • Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.
  • Serves as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions.
  • Proactively identifies project issues to the project team and supports mitigation plans.
  • Attends cross functional meetings, vendor meetings and kick-off meetings as required.
  • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
    • The position will suit an outgoing and ambitious regulatory affairs professional with a desire to to get involved in a pivotal front line position supporting the business growth. You will need strong academics, excellent communication skills and a strong practical Regulatory background.

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