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Regulatory Affairs Executive

Rutherford Briant
Job LocationBasildon
EducationNot Mentioned
Salary£35,000 - £45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Rutherford Briant are currently recruiting for a Regulatory Affairs Executive to join a rapidly expanding Regulatory Affairs team in Basildon.This is a great opportunity for a capable regulatory professional to join a very acquisitive business with exciting plans. This is a broad ranging role and would suit a regulatory professional seeking to expand their general experience within regulatory affairs.Key responsibilities:

  • Provides operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
  • Supports the preparation of core dossiers and submissions for global roll out.
  • Authors and collates supporting documents for submission, including M1 and M3 dossier sections as necessary, justification documents and Product Information.
  • Supports labelling processes, providing artwork approval prior to submissions and printing.
  • Monitors labelling compliance across multiple markets, coordinates the review of the Company Core Data Sheet (CCDS) and subsequent safety updates globally.
  • In collaboration with global partners, consultancies and distributors, supports the compilation of global regulatory intelligence to form a global regulatory strategy.
  • In collaboration with senior management and project strategy teams, supports global cross functional regulatory strategies.
  • Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting.
  • Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.
  • Communicated with local health authority, local consultancies/ distributors and internal stakeholders, as needed, to ensure timely and accurate submissions.
  • May support or facilitate 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.
  • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
    • Requirement:
  • Bachelors degree is required. Scientific/Health/Pharma field.
  • At least 4 years of related experience within a pharmaceutical company, CRO, CMO or similar
  • Experience in CCDS and SmPC updates, labelling processes and artwork approval.
  • Must be able to communicate comfortably and effectively with regulatory authorities.

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