Regulatory Affairs Officer - Pharmaceuticals

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.

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.

• 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.

• 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.