Regulatory Affairs Executive

Regulatory Affairs Executive- Wrexham- Hybrid working.

I\’m currently partnering with a well-established pharmaceutical manufacturer based in Wrexham, known for producing generics and sterile products for global markets. This is a fantastic opportunity for a Regulatory Affairs professional with 2-3 years of experience to take the next step in their career and grow within a reputable, international business.

Key responsibilities for the Regulatory Affairs Executive

• Determine and communicate submission requirements; assess documentation for regulatory acceptability
• Prepare and compile documentation for marketing authorisations, renewals, eCTD baselines, and variations
• Ensure dossiers are clear, consistent, and complete, with all open questions resolved
• Respond to internal and external regulatory information requests
• Commission and review artwork for submission suitability, regulatory compliance, and brand alignment
• Coordinate and prepare submission packages for regulatory agencies
• Support development of variation submission strategies
• Liaise and negotiate with regulatory authorities to secure favourable outcomes
• Collaborate with third‑party companies, including contract manufacturers
• Draft Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs)
• Operate and improve administrative procedures within the Regulatory Affairs department
• Publish electronic submissions using dedicated software
• Comply with and contribute to the development of departmental and company SOPs
• Represent Regulatory Affairs in internal meetings as directed
• Engage with the Pharmaceutical Quality System to maintain integrity and support performance tracking

Requirements for the Regulatory Affairs Executive

• Bachelor\’s degree in a scientific discipline
• Good understanding pharmaceutical GMP
• Strong Written and verbal communication.
• Experience in different pharmaceutical markets

Benefits for the Regulatory Affairs Executive

• Pension scheme – 7% matched contribution
• Rewards platform – discounts on shopping, restaurants, holidays and more
• Generous holiday allowance
• Salary sacrifice schemes
• Sports and Social club
• Subsidised canteen
• Free parking

To apply for the Regulatory Affairs Executive, please contact Rezaune at Smart4Sciences.