Lead Compliance Specialist

4 weeks ago

Kent, United Kingdom Hyper Recruitment Solutions LTD Full time

Position Overview:

We are seeking a Lead Compliance Specialist to become a vital part of a prominent organization in the pharmaceutical sector.

In this role, you will be essential in overseeing the product life cycle and managing post-authorization modifications within the UK market, with a focus on Chemistry, Manufacturing, and Controls (CMC), clinical trials, safety assessments, and product information updates.

Key Responsibilities:

  • Engage with regulatory authorities and facilitate communication regarding product variations.
  • Develop and approve product information and artwork to ensure regulatory adherence.
  • Ensure that CMC practices are in line with regulatory standards, providing clear justifications for new product licenses and variations.

Qualifications:

To excel in this role, candidates should possess:

  • Demonstrated experience in Regulatory Affairs within the pharmaceutical industry.
  • Excellent communication and project management capabilities.
  • Proficiency in Microsoft Office and regulatory submission platforms.

Keywords: Compliance Specialist | Pharmaceutical | Product Life Cycle | CMC | Clinical Trials | Safety | Product Information | Regulatory Submission | Variations | Marketing Authorization Transfer | eCTD | EMC | MHRA | CESP | Pharmacovigilance

We are excited to assist you in your career journey.

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