Senior Regulatory Compliance Specialist

8 hours ago

Cork, Cork, Ireland beBeeCompliance Full time €80,000 - €100,000
Regulatory Specialist Job

We are seeking a highly skilled Regulatory Specialist to join our team. This is a 12+ month contract position, full-time, with possible contract extension.

About the Role:

The successful candidate will be responsible for certifying Intermediate and API batches manufactured on site in compliance with regulatory requirements. They will also ensure continuous development and maintenance of compliance to GDP; GMP; Marketing authorization; IMPD; Import License, etc., depending on product requirements.

  • Certify Intermediate and API batches manufactured on site in compliance with regulatory requirements.
  • Ensure continuous development and maintenance of compliance to GDP; GMP; Marketing authorization; IMPD; Import License, etc.
  • Represent the Regulatory team at the site change control committee to ensure that any issues with regulatory impact are notified to health authorities and mitigated as required.
  • Attend Quality Review Meetings.
  • Serve as the site point of contact for the quality department for intermediates outsourced to CMOs and coordinate the release of intermediates for importation into the EU.
  • Support QA colleagues with product quality/license impact assessment for Quality Issue.

Qualifications and Skills:

To be successful in this role, you will need to have:

  • Fulfilled the educational requirements as outlined in Article 49 of Directive 2001/83/EC as an acting QP.
  • Degree qualified.
  • Validated experience within regulated biologics/pharmaceutical industry within a cGMP manufacturing environment, with knowledge and proficiency in batch release and compliance.
  • Experience performing the duties of a Qualified Person in a manufacturing facility.
  • Gained experience in regulatory inspections in either hosting, presenting, or defending site positions.
  • Knowledge and experience in FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
  • Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.
  • Candidates must have valid working VISA in Ireland or European Passport.

What We Offer:

This is a fantastic opportunity to work with a global pharmaceutical company based in Cork. You will have the chance to develop your skills and expertise in a dynamic and challenging environment.

How to Apply:

Please submit your CV and cover letter to us. We look forward to hearing from you.

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