Regulatory Affairs/Quality Assurance Professional
Cheshire, Northwest England
Reed Scientific are working with a leading global healthcare company specializing in pharmaceuticals and medical devices, and they are seeking an experienced Regulatory Affairs Professional to join their team. In this role, you will be responsible for managing product regulatory activities for our licensed medicinal products in the UK and Ireland. Your primary focus will be on preparing, reviewing, and submitting variations to regulatory authorities (HPRA and MHRA). You will also update Summary Product Characteristics (SPCs), Patient Information Leaflets (PILs), and product labels.
Responsibilities:
- Prepare, review, and submit regulatory variations for licensed medicinal products.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Assess and prepare National and DCP/MRP regulatory submissions (Type II, Type IB, Type IA, Article 61(3), and Self Certs).
- Coordinate artwork changes, including mock-ups and PPM (SmPC/PIL/Labels).
Desirable Experience:
- Previous experience in regulatory submissions for Licensed Prescription-Only Medicines (POMs).
- Familiarity with regulatory guidelines and procedures.
- Strong attention to detail and excellent organizational skills.
- Ability to work independently and meet deadlines.
If you have the relevant experience and are passionate about regulatory affairs, we encourage you to apply. Please follow the link to apply.