LSC have a great contract opportunity for a Regulatory Affairs CMC Manger to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
- Timely compilation and management of all necessary documentation for regulatory submissions. Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
- Liaise with U.S. and Shanbally teams to prepare GMP documentation to support global submissions for product registrations and/or renewals.
- Participate in cross-functional project teams as a regulatory CMC representative for project specific discussions. Ensure consistent communication within the department and with other functional areas.
- Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
- Assist in the preparation for interactions with global regulatory authorities
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 Grainee Hodnett at LSC on 021-4777329 if you have any more questions about this opportunity!