Regulatory affairs specialist (PLG)

Roles and Responsibilities

Responsibilities:

1. Submission and Approval Process:

• Prepare and submit Manufacturing Licence Applications (MLA) for new products and site transfers in the UK and EU.

• Support and contribute to the preparation and submission of Marketing Authorisation Applications (MAA) via UK national, MRP/DCP, and EU procedures.

• Support Technical and Site Transfer Applications related to product launches, manufacturing changes, and regulatory updates.

• Assist with CTD/eCTD dossier preparation, compilation, and lifecycle management in accordance with MHRA and EMA requirements.

2. Lifecycle Maintenance:

• Manage post‑approval regulatory activities, including Variations, Renewals, Line Extensions, and MAH Transfers, across UK and EU markets.

• Maintain approved Marketing Authorisations throughout the product lifecycle, ensuring timely and compliant submissions.

• Handle updates to Product Information (SmPC, PIL, labelling), artwork, and packaging, ensuring alignment with approved documentation and regulatory standards.

3. Regulatory Compliance:

• Monitor and interpret UK and EU regulatory legislation, guidelines, and regulatory intelligence updates.

• Ensure compliance with UK Human Medicines Regulations and EU regulatory frameworks.

• Support inspection and audit readiness (internal and external) by maintaining compliant regulatory documentation.

4. Communication:

• Act as a key liaison with MHRA, EMA, and national competent authorities in the EU.

• Provide regulatory guidance and support to cross‑functional teams (Quality, Supply Chain, Pharmacovigilance, Commercial).

• Coordinate and contribute to responses to regulatory authority questions and requests for information.

5. Software Utilisation & Data Management:

• Use regulatory and document management systems to prepare, track, and archive submissions and correspondence (e.g. Microsoft Office Suite, Veeva Vault or comparable EDMS, LorenZ, Trackwise, PromoMats).

• Efficiently retrieve, analyse, and manage regulatory data to support submissions and lifecycle activities.

Experience:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree is a plus).

• 3–7 years of experience in Regulatory Affairs, with exposure to UK and EU regulatory environments.

• Experience supporting lifecycle maintenance of medicinal products.

• Hands‑on experience with MAA support activities, CTD/eCTD, product labelling, line extensions, Product Information updates, and artwork review.

• Good understanding of MHRA and EMA procedures and post‑approval regulatory requirements.

• Experience working with regulatory systems and databases (Microsoft Office, Veeva Vault or similar EDMS, LorenZ, Trackwise, PromoMats).

• Fluent in English (written and spoken); additional EU languages are a plus.

• Strong organisational skills and ability to manage multiple priorities in a dynamic environment.

• Experience in coordination or project support is a plus.

• Exposure to promotional and non‑promotional regulatory activities is an advantage.