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 or email me at [email].
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