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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 or here more information, please contact Rezaune at Smart4Sciences on (phone number removed) or email me at
