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Regulatory Compliance Specialist

2 months ago


Irvine, North Ayrshire, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time
About the Role

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at GSK HQ in London. As a key member of our Quality Assurance team, you will be responsible for ensuring compliance with global, regional, and national regulatory requirements and GMP guidelines.

Key Responsibilities
  • Manage operations to allow EU/UK certification of batches of pharmaceutical products imported by the Principal Trading Company (PTC).
  • Ensure QP Importation operation is inspection ready and participate in regulatory inspections of the QP certification process on behalf of the PTC.
  • Perform Audits of the importation supply-chain (compliant to GMP, GDP, and MIA authorization).
  • QP certify all batches of pharmaceutical products imported into UK in accordance with all applicable laws and guidelines.
  • Act as key point of contact with non-EU/UK based GSK manufacturing sites and external supply quality and GMP audit teams for products manufactured outside the EU/UK to ensure QP certification requirements are maintained.
  • Act as a key point of contact with R&D for new products being imported into EU/UK ensuring a testing location is identified and resourced (as required) and QP certification and release activities meet programme timelines.
About You

You will be a qualified QP with sound knowledge of global, regional, and national regulatory requirements and GMP guidelines. You should be comfortable dealing with issues that may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise. You will be resilient and calm under pressure with strong people skills and a strong continuous improvement mindset.

What We Offer

GSK offers a range of benefits to its employees, including competitive base salary, annual bonus based on company performance, opportunities for on-the-job training, and access to healthcare and wellbeing programmes.