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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
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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.
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