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Regulatory Affairs Manager

  • Location

    Basildon, Essex

  • Sector:

    Operations & Middle Office

  • Job type:

    Permanent

  • Salary:

    Salary To be Discussed

  • Contact:

    Simon Smith

  • Job ref:

    SS-RegAffairsManager_1630924602

  • Published:

    17 days ago

Our Client, a leading Pharmaceuticals Organisation in Essex are looking to hire a Regulatory Affairs Manager to join their fast expanding team.

Main responsibilities & duties as Regulatory Affairs Manager Include:

  • Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
  • Leads 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.
  • Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting.
  • 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.
  • Facilitates communication between the HA(s) and the project team. Attends and generally leads agency meetings, if required.
  • Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
  • Proactively identifies project issues to the project team and supports mitigation plans.
  • Attends cross functional meetings, vendor meetings and kick-off meetings as required.
  • Mentors and/or manages other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.
  • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
  • Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions.

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