Pharmaceutical Regulatory Compliance Specialist

6 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Part time €45,000 - €85,000
Regulatory Affairs Expert

Clinigen is a rapidly growing global pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle.

The Qualified Person will have oversight of business activities relating to contract manufacturers, suppliers and technical due diligence activities. The role includes executing the legal duties of a Qualified Person as defined under Directives 2001/83/EC and 2001/20/EC, in compliance with EudraLex Vol. 4 Annex 16 and Annex 13, the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (the Orange Guide) as published by the MHRA, and any other applicable laws, guidelines or regulations required by any group company.

  • To ensure that manufacturing activities at assigned CMOs are appropriately managed in accordance with EU GMP under directive 2003/94/EC and in compliance with EudraLex Vol. 4 Annex 16 and EudraLex Vol. 4 Annex 13.
  • To ensure that manufacturing activities relating to CTS services for IMPs manufactured and packed at overseas partner facilities are conducted in accordance with equivalent standards to those required by EU GMP.
  • To ensure that the operations do not compromise the quality of medicines.
  • To ensure that adequate records are maintained relating to the legal duties of the QP.
  • To participate in the audit of the Clinigen quality system and to carry out independent audits of marketing authorisation holders necessary suppliers and partner facilities and processes.
  • To ensure that appropriate standards of GDP and GMP are maintained.
  • To employ due diligence in the discharge of his/her duties and to report to senior management and the MHRA any suspicious events of which he/she becomes aware.
  • To be named on site MIA licenses and perform the legal duties of the QP in accordance with directives 2001/83/EC and 2001/20/EC and in compliance with EudraLex Vol. 4 Annex 16 and EudraLex Vol. 4 Annex 13.
  • Eligible to act as a QP under directive 2001/83/EC preferably under the permanent provisions.
  • Experienced in aseptically produced sterile products ideally lyophilized dosage form.
  • Ideal experience of QP certification for release of clinical trial materials under directive 2001/20/EC inclusive of dosage form manufacturing and clinical packing.
  • Demonstrable business and commercial awareness combined with patient focus.
  • Experience of working independently and as part of a team.
  • Experience of working across multiple time zones and in global business cultures particularly US and Japan.
  • Must also have knowledge of:
  • Directive 2001/20/EC as amended on the wholesale distribution of medicinal products for human use.
  • Official Guidelines on GDP of medicinal products for human use.
  • The conditions of the MIA for which he or she is nominated.
  • The products traded under the licence and the conditions necessary for their safe storage and distribution.
  • The categories of persons to whom products may be distributed.
  • Familiar with any changes that may be introduced into legislation and any variations that may be granted in respect of the licence for which he/she is named as RP.
  • Comply with the expectations of their professional body in relation to CPD.
  • Ideal experience of the Quality Assurance and regulatory environment for the supply of unlicensed medicines used to support patient needs when a licensed medicine alternative is not available this could be in local or overseas countries.

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