LSC have a great contract opportunity for an Associate Director - Regulatory CMC to join a Cork based Biopharmaceutical company.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Working closely with Quality Assurance, Quality Control and Manufacturing groups to assure the relevant product and regulatory expectations are met.
- Act as the primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe.
- Timely compilation and management of all necessary documentation for regulatory submissions.
- Ensure submissions are of high quality; that content and format of regulatory submissions comply with application regulations and guidelines governing the development and marketing of drugs and/or biologics.
- Provide regulatory CMC support for Impact assessment to change control, deviation and inspection management.
- Coordinate and track regulatory commitments related to the site.
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!
Apply via this advert or contact Kathy Gillen at LSC on 021-4777329 if you have anymore questions about this Associate Director - Regulatory CMC opportunity!