LSC has an exciting opportunity for a Regulatory Affairs Specialist to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
- Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner
- Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
- Provides the necessary CM&C commitment information to site personnel
- Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
- Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation, and stability protocols
- Will participate in Lilly’s Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives
ABOUT YOU – ARE YOUR SKILLS A MATCH?
- Bachelor’s Degree in sciences discipline (e.g., chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
- Prior Regulatory CMC experience (> 3 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Pawel Jurkiewicz at LSC on to discuss this new role in detail or apply directly via this advert