Regulatory Affairs Director

1 day ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €100,000 - €150,000

Job Overview:

We are seeking a seasoned Regulatory Affairs professional to lead regulatory support for assigned programs, ensuring sound planning and tactical implementation of US and international regulatory submission strategies.

The ideal candidate will have expertise in CMC regulatory strategies, strong collaboration skills, and experience serving as primary RA-CMC contact to Health Authorities.

  • Key Responsibilities:
  • Formulate CMC regulatory strategies based on current regulatory intelligence.
  • Collaborate with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks.
  • Identify required documentation and manage delivery of approved technical documents in accordance with project timelines.
  • Manage preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications.
  • Support evaluation of manufacturing changes for potential impact on products.
  • Provide expert review of CMC documentation supporting regulatory submissions and communications.

Requirements:

  • 10-12+ years of related work experience, including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry.
  • Bachelor's degree in chemistry or closely related field; advanced degree is preferred.

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