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Regulatory Affairs Expert

1 week ago


Ennis, Clare, Ireland Cregg Group Full time

Cregg Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in Co. Clare.

Job Description

The Senior Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.

This role will provide support to functional project teams on Biological Evaluations for new and existing products/indications and be responsible for implementing biological evaluation plans.

  • Lead research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
  • Respond to requests from notified bodies; competent authorities and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information.
  • Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.

Provide regulatory direction to development project teams as a core team member.