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Regulatory Affairs Manager

4 months ago

Kent, United Kingdom Cpl Life Sciences Full time

Job Title: Regulatory Affairs Manager (Parallel Import)

Job Type: Full-time, permanent position

Location: East London/ Kent – (Hybrid, 3 days on-site, 2 days from home)

Remuneration: Competitive salary and benefits package



Are you the right candidate for this opportunity Make sure to read the full description below.

Overview:

Regulatory Affairs Manager opportunity working for a family-run pharmaceutical company that specialise in generic, OTC, medical devices, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the team and support all areas of Regulatory Affairs.


Seeking a detail-oriented Regulatory Affairs Manager with experience in Parallel Imports of medicines to join the business. The ideal candidate will ensure compliance with regulations and laws governing the industry.


Responsibilities:

  • Prepare and submit regulatory filings and documentation to appropriate regulatory parallel import agencies (MHRA).
  • MA transfers and initial MAA applications in the UK and IRE markets.
  • Prepare and submit parallel import applications to the MHRA.
  • Monitor and interpret regulatory requirements and communicate changes (variations) to stakeholders.
  • Submit variations (1a, 1b and type 2) timely.
  • Develop strategies for regulatory submissions in coordination with stakeholders
  • Collaborate with cross-functional teams (QA) to ensure compliance with regulations
  • Maintain current knowledge of regulations, guidelines, and standards
  • Management of packaging components stock levels.

Skills:

  • A degree in a related field
  • least 4+ years of experience working in the Regulatory Affairs sector
  • Previous experience in Parallel Imports
  • Understanding of quality assurance principles in parallel imports
  • Strong written and verbal communication skills
  • Able to work independently and in a team environment


Please note to apply for this position you will need to be based in the UK and hold the full right to work in the UK. For more details please reach out to lucy.kirkaldy@cpl.com