Regulatory Compliance Specialist

3 weeks ago


Montrose, Angus, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time
About the Role:

The Regulatory Compliance Specialist will be responsible for ensuring the importation of pharmaceutical products into the EU/UK is compliant with all relevant laws and regulations. This includes managing operations to allow EU/UK certification of batches of pharmaceutical products imported by the Principal Trading Company (PTC). The successful candidate will also ensure the QP Importation operation is inspection ready and participate in regulatory inspections of the QP certification process on behalf of the PTC.

Key Responsibilities:

  1. Managing operations to allow EU/UK certification of batches of pharmaceutical products imported by the Principal Trading Company (PTC).
  2. Ensuring the QP Importation operation is inspection ready and participating in regulatory inspections of the QP certification process on behalf of the PTC.
  3. Auditing the importation supply-chain compliant to GMP, GDP, and MIA authorization.
  4. QP certifying all batches of pharmaceutical products imported into the UK in accordance with all applicable laws and guidelines.
  5. Acting as a 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.
  6. Acting as a key point of contact with R&D for new products being imported into the EU/UK ensuring a testing location is identified and resourced (as required) and QP certification and release activities meet programme timelines.

Location:
The role can be based at any GSK site in the UK, but please note that there is a requirement to travel to Barnard Castle (County Durham) to review and approve batch-release (as the need arises). It is anticipated that this will be circa 3 to 4 times a quarter.

About You:
The successful candidate will be a qualified QP (Qualified Person) with sound knowledge of global, regional, and national regulatory requirements and GMP guidelines. They 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. They will be resilient and calm under pressure with strong people skills.



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