Regulatory Affairs Officer

Puddington, Cheshire West and Chester
3 months ago
Applications closed

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Regulatory Affairs Officer – Pharmaceuticals

Salary: £40,000 – £50,000 DOE.

Are you a detail-oriented Regulatory Affairs professional with a passion for ensuring pharmaceutical compliance across global markets? This is an excellent opportunity for an RA officer to join a well-established pharmaceutical manufacturer with a strong reputation for innovation and quality.

The Role

As a Regulatory Affairs Officer / RA Officer, you’ll play a key role within the regulatory team supporting product registrations, variations, renewals, and submissions across the UK, Ireland, and international territories.

You’ll liaise with regulatory authorities and third-party partners, ensuring dossiers and submissions are of the highest quality and in line with legislative requirements.The suitable RA offcier will have the following responsibilities.

Key Responsibilities:

  • Prepare, compile and submit variations, renewals, and new product applications (MAAs) in eCTD format.

  • Liaise with MHRA and other authorities to ensure timely approvals.

  • Review and coordinate product artwork and labelling in line with current regulations.

  • Maintain and update regulatory databases and documentation.

  • Contribute to continuous improvement within the company’s Pharmaceutical Quality System.

  • Monitor evolving legislation and provide regulatory guidance to internal teams.

    About You:

  • Degree (or equivalent) in a life sciences discipline.

  • Experience within pharmaceutical regulatory affairs (ideally with exposure to UK/EU submissions).

  • Excellent attention to detail and ability to manage multiple priorities.

  • Strong communication and organisation skills.

  • TOPRA membership and OTC experience would be advantageous but not essential.

    What’s on Offer:

  • Competitive salary (£40,000–£50,000 DOE)

  • Hybrid working

  • 7% matched pension scheme

  • Rewards and discounts platform

  • Generous holiday allowance

  • Salary sacrifice schemes

  • Subsidised canteen and free parking

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