Description
A global Biopharmaceutical company is currently seeking a Regulatory Site Officer to join their growing team in Co. Waterford. This is a 12month fixed-term contract. It is an excellent opportunity to be part of a faced-paced and expanding manufacturing environment.Reporting to the Head of Regulatory Affairs, the successful candidate will be responsible for activities which include: supporting New Product Development Projects and for the continuous improvement of Regulatory Affairs processes and procedures.
Key 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.
Qualifications and Requirements:
- Degree/Diploma in Science, Pharmacy or related discipline is essential.
- 3+ years experience in a fast paced regulatory/compliance/quality team at a pharmaceutical manufacturing site.
- Excellent communication skills (interpersonal, presentation & writing).
- Ability to effectively communicate technical & non-technical information.
- Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment.
- Initiative - able to work in a self-directed manner to see issues through to completion.
- Highly motivated and has the ability to multi-task.
If you think you are a good fit for this role please call me, Olivia Doggett, on or apply directly to this advert.