Regulatory Affairs Officer - Pharmaceuticals

Reference: GG10194_1750850589

Regulatory Affairs Officer - Pharmaceuticals & Medical Devices - Hull


Are you a Regulatory Affairs professional with a keen eye for compliance and a passion for bringing life-changing products to market? Smart4 Sciences partnering with a well-established pharmaceutical company who are looking to add a Regulatory Affairs Officer to their growing team.

About the Role:

As the Regulatory Affairs Officer, you'll play a critical part in ensuring regulatory compliance across UK, EU, and international markets. From product registration to post-market vigilance, you'll support the full lifecycle of innovative pharmaceutical and medical device products.

Key Responsibilities:

  • Compile and submit regulatory dossiers (new registrations, variations, renewals, CTAs).

  • Maintain current knowledge of MHRA, EMA, FDA, UK MDR 2002, and EU MDR 2017/745 requirements.

  • Liaise with regulatory bodies to resolve queries and secure timely approvals.

  • Manage post-market surveillance, change controls, and regulatory impact assessments.

  • Approve labelling and packaging for regulatory compliance.

  • Maintain regulatory databases and technical documentation.

What You'll Need:

  • Degree in a scientific discipline, chemical engineering or similar (or equivalent experience).

  • 2+ years of regulatory affairs experience in pharma or medical devices.

  • Strong understanding of GMP, GDP, and ISO 13485.

  • Analytical mindset with excellent communication and problem-solving skills.

  • Experience influencing stakeholders and working cross-functionally.


Ready to take the next step in your regulatory career?
Apply now or contact Gareth Gooley on at Smart4 Sciences for a confidential conversation.

£28,000.00 - £35,000.00
Per annum
Negotiable

Hull

Permanent

Added 25/06/2025
Reference: GG10194_1750850589

Regulatory Affairs Officer - Pharmaceuticals

Hull
Permanent

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