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Search Results for Regulatory Affairs Director
Job Title. Location Salary Actions

Senior Director, Regulatory Affairs

Our client is a Biopharma organization from the US with office based in Dublin in the last year. They are seeking a Senior Director of their Regulatory Affairs. The incumbent will be responsible for leading the Regulatory Affairs functions within Europe and specific additional regions. A scientific degree with a minimum of 5 years Regulatory experience (10 years Pharmaceutical experience) is required as a minimum. 20% travel associated with this role. Role/Responsibilities: • Ensure appropriate support for program maintenance, post-marketing studies and development ...

Location: Dublin,
Senior Director, Regulatory Affairs
Dublin Not Disclosed

CMC Regulatory Affairs Director

Our client is a Biopharma organisation with offices in Dublin. They are currently seeking a Director, CMC Regulatory Affairs, who will be responsible for providing tactical and strategic regulatory support for marketed products and development programs. A degree in Science with at least 8 years relevant CMC Regulatory experience is essential. Role/Responsibilities: • As part of his/her responsibilities, the Director will collaborate with key functional areas (including Technical Operations and Quality) to prepare high quality, timely, and effective regulatory...

Location: Dublin,
CMC Regulatory Affairs Director
Dublin Not Disclosed

Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to Ge

Location: Dublin,
Head of Quality & Regulatory Affairs
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior CMC Reg Affairs Specialist Dublin Not Disclosed
Senior CMC Reg Affairs Specialist Dublin Not Disclosed
Senior CMC Reg Affairs Specialist Dublin Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Senior CMC Reg Affairs Specialist Dublin Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Senior CMC Reg Affairs Specialist Dublin Not Disclosed

Regulatory Affairs Director Career Profile

Regulatory Affairs Director


A strategic role which is responsible for the overall direction of the company, often involved in a smaller company at start-up stage. The spec below refers to an example position in the Medical Device sector

Key Responsibilities

  • Compliance with and adherence to medical device regulations in the geographical areas mentioned.
  • Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
  • Introduce and managed design control and quality systems.
  • Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
  • Dealing directly with relevant local regulatory bodies.
  • Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
  • Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
  • Authored and deliver product presentations to physicians and to sales personnel.
  • Liaise with international colleagues in relation to ongoing clinical monitoring.

Skills / Experience

  • B.Sc. degree in Life Sciences, advanced degree preferred.
  • 10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
  • Knowledge of GI / urinary diseases.