Regulatory Affairs Scientist is required by a leading Global Pharmaceutical company based in Cork. The Cork campus has produced small molecule API for over 30 years and has built a new Biotechnology facility which will deliver the next generation of products to the global market. For over three decades the site has succeeded in fostering a working environment where team members take pride in both the excellence of their personal
and collective contributions and the positive benefits they provide to patients around the world. This is an opportunity to work for a household name and to grow your career.
In this role the new Regulatory Affairs Scientist will:
o Will oversee the preparation and documentation of specified regulatory submissions
o Provide regulatory leadership and direction for products listed as primary responsibilities
o Will develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS (process and technology transfer), manufacturing, quality control and quality assurance
o Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner
o Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
o Provides the necessary CM&C commitment information to site personnel
o Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
o Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols
The Regulatory Affairs Scientist requires:
o 3rd level degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
o 5+ years relevant regulatory affairs experience in the pharmaceutical/bio-pharmaceutical industry.
o Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing.
o Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
If this role is of interest, please call Regina at LSC on 021 4777 329 or apply directly through this advert.