Senior Pharmaceutical Compliance Specialist

2 weeks ago


Cork, Cork, Ireland beBeeRegulatory Full time €82,829 - €112,198
Regulatory Professional Opportunity

We are seeking a talented Regulatory Scientist to join our Global Regulatory Affairs team in Cork. As a key member of our team, you will play a critical role in ensuring the successful preparation and submission of regulatory documents for pharmaceutical products.

Key Responsibilities:
  • Provide regulatory support for existing drug substances and drug products by preparing and maintaining relevant regulatory submission documentation.
  • Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities and contract manufacturers.
  • Ensure successful preparation of CMC dossiers and variation packages to support product submissions.
  • Develop and execute regulatory strategies on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives.

Requirements:

  • Minimum college degree (BSc) in a related biological and life science field; advanced degree (MSc, PhD, PharmD) preferred.
  • Solid regulatory experience in a pharmaceutical or biotech setting.
  • Strong knowledge of regulatory and compliance guidelines within pharmaceuticals/bio-pharmaceuticals.
  • Strong knowledge of manufacturing and quality work processes as well as GMP compliance.


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