Regulatory Affairs Specialist

3 weeks ago


High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full time
Job Title: Senior Regulatory Affairs Specialist

Location: Hybrid (South East England)

Company: World-Leading Consumer Healthcare Company

Job Purpose:

As a Senior Regulatory Affairs Specialist, you will leverage your extensive knowledge of the regulatory landscape to ensure compliance and successful product registrations, including new drug applications, cosmetics, and medical devices. Your strategic input will guide product development teams in navigating local regulations and approvals, optimising compliance processes, and maintaining high-quality standards.

Key Responsibilities:
  1. Develop and implement regulatory strategies for product submissions.
  2. Assess quality, preclinical, and clinical documentation for compliance.
  3. Monitor regulatory review processes and communicate with health authorities.
  4. Review promotional materials and product artworks for regulatory compliance.
  5. Ensure all products meet local regulations and quality system requirements.
Qualifications:
  1. Bachelor's degree (or higher) with 6+ years of relevant experience.
  2. Expertise in Medicinal Products, Cosmetics, and/or Medical Devices.
  3. Strong understanding of Regulatory frameworks and consumer healthcare environments.


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