Description
Regulatory Site Officer - Global Bio-pharmaceuticalA global Bio-pharmaceutical company is currently seeking a Regulatory Site Officer to join their growing team in Co. Waterford. This is a permanent role and it is an excellent opportunity to be part of a faced-paced and expanding manufacturing environment.
The Regulatory Site officer role will involve working as part of the RA team you will have a key role in supporting activities at an expanding manufacturing site where both oral dose and aseptic parenteral drug products are manufactured for global markets. In addition, combination products and medical devices will also be produced on site.
Responsibilities:
-Review and evaluate the regulatory impact of proposed changes at the site.
-Support New Product Development Projects and continuous improvement initiatives for existing products/processes
-Provide guidance to project teams on the technical data package needed to support filings for changes to product operations (for commercial and clinical trial use) and product transfers to and from site.
-Compilation of information for use in global filings.
Ensure appropriate communication of RA variation approvals, indicating -when approved changes with RA impact can be implemented.
-Compilation and maintenance of Product Specification Files
-Maintenance of Site Master Files/Plant Master File.
-Maintain IMB manufacturing licences and provide RA guidance into major deviations as appropriate.
-Support Annual Report preparation as required
-Continuous Improvement of Regulatory Affairs processes and procedures
-Review and approval of site documentation ensuring compliance with regulatory commitments and registered product details (e.g. batch records, material specifications, protocols and reports (e.g. PQs and PVs), stability documentation, etc
-Review and approval of artwork
Experience required for the regulatory site officer role:
-Minimum 5+ year's experience in a fast paced regulatory/compliance/quality team within a bio-pharmaceutical or medical device manufacturing facility required with appropriate regulatory experience.
-In-depth working knowledge of Regulatory aspects of Medical Devices (ISO 13485) and combination therapies
-Excellent communication skills (interpersonal, presentation & writing)
3rd Level Degree in Science, Pharmaceutical or related discipline is essential
-Ability to effectively communicate technical & non-technical information
An excellent salary of €45,000 - €55,000 plus benefits is on offer. If you are interested in this role please apply and please contact me Adele Moran on for more information and immediate consideration.