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Senior Regulatory Team Lead

Senior Regulatory Team Lead

Permanent Full Time
Pharmaceutical Quality
Ireland
Dublin
Clarity Recruitment is delighted to have been retained in the search for a Senior Regulatory Team Lead.

Objective
  • Working within an environment with an international outlook, manage the team of Regulatory Affairs Officers and submissions process for MRP/DCP procedures, achieving long term account goals in line with the company vision and values
  • Manage and oversee the coordination of regulatory submissions assigned to RA International Submissions Team and ensure registration deadlines are met
Duties
  • Manage and oversee the coordination of regulatory submissions assigned to RA International Submissions Team and ensure registration deadlines are met
  • Ensure that documentation compiled by team is complete and complies with applicable regulatory requirements
  • Ensuring that information is exchanged and weekly and monthly reporting is followed by the RA International Submissions Team
  • Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies.
  • Proactively inform the RA Manager and other involved functions regarding all identified risks related to the planned MAA.
  • Review of regulatory submissions/MAAs for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are met.
  • Prepare, as per internal process, the data needed to make all required registration fees in a timely manner.
  • Dispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmed.
Job – related work experience required:
  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Min 4-5 year experience in a regulatory affairs environment in the pharmaceutical industry preferably with management/supervisory experience
  • Detailed knowledge of EU current registration requirements for dossier preparation and procedure running
  • Solid knowledge of specific national requirements in EU and other regions
  • Knowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)

For more information and to apply for this role please call Marc Bentley on 353 1 582 0027 or e-mail marc@clarityrecruitment.ie

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