Regulatory Affairs Professional

1 day ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €96,000 - €124,000
Job Overview

Regulatory Affairs professional sought to lead CMC regulatory support for assigned programs.

Key responsibilities include formulating strategic CMC regulatory plans, collaborating with cross-functional teams, and managing the preparation of regulatory submission documents.

Requirements include 8+ years of experience in Regulatory Affairs CMC, a bachelor's degree in chemistry or a closely related field, and excellent working knowledge of international regulatory requirements.

Candidates should possess strong communication and organizational skills, with the ability to work effectively across teams and functions.

This is an individual contributor position; however, there is the possibility for supervising consultants/contractors and/or interns.

Responsibilities
  • Develop and implement regulatory strategies and guidelines within the team.
  • Manage the preparation, authoring, and maintenance of regulatory submission documents pertaining to CMC data.
  • Collaborate with external vendors and regulatory health authorities to ensure effective communication and coordination.
Qualifications
  • Minimum 8 years of experience in Regulatory Affairs CMC in the biotech/pharmaceutical industry.
  • Proven experience serving as a primary RA-CMC contact to Health Authorities.
  • Bachelor's degree in chemistry or a closely related field; advanced degree preferred.
  • Excellent working knowledge of international regulatory requirements and environment.
What We Offer
  • A dynamic and collaborative work environment.
  • Opportunities for career growth and professional development.
How To Apply

Send your resume and a cover letter detailing your experience and qualifications.

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