LSC have a great contract opportunity for a Senior Associate Regulatory Affairs to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. In July 2015 the site opened a $300million investment, which added significantly to the site's laboratory, filling, packaging, and distribution (including cold chain) capabilities. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the company's global supply chain.
If you have a bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline) and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- The Associate Regulatory Affairs is responsible for the registration document(s) procurement, preparation, and coordination.
- The Associate Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.
Works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.
- Registration document(s) procurement, preparation, coordination submission and archival
- Coordinates legalization and delivery of registration documents following the instructions provided in the request.
- Maintains tracking and organization of documentation, including uploading in CSD tool or another document repository.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Candidates MUST have GMP site experience, with some sort of reg experience
Candidate needs to Regulatory filings at least
- Excellent written and verbal skills
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
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 Siobhan Cummings in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert