PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our growing life sciences company. In this role, you will ensure UK and EU regulatory compliance throughout the product lifecycle, from development and approval to post‑market maintenance, in line with MHRA and EMA requirements.

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.

Regulatory Affairs Specialist - UK Legislation

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