Regulatory Affairs Executive

Wrexham
3 months ago
Applications closed

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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

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