Job Description:
Global Pharmaceutical company, based in Cork, Ireland - looking for Regulatory QA specialist.
The successful candidate will be responsible for executing regulatory and compliance related tasks and project activities supporting both the Quality Assurance and Global Regulatory Affairs department's functions.
This will be 12-month contract position, full-time, hybrid, with possible extension.
The role:
* Maintenance of the Clinical and Commercial Health Products Regulatory Authority (HPRA) Manufacturing Licenses by preparing and submitting application updates in a timely manner.
* Collaborate effectively with Notary Public on the management of notarization and legalization requests. Ensure availability of related PO’s and appropriate logging and tracking of requests.
* Assist and co-ordinate with Regulatory Management on Country Specific Requests (CSRs) for initial registrations and renewals.
* Co-ordinate paper-based inspections for product renewals and new submissions as per Health Authority timelines.
* Support new submissions for products by reviewing relevant dossiers.
* Support post-approval submissions for products by preparing and/or reviewing relevant dossier sections, participating in issue escalation and coordinating country specific requests associated with post-approval changes e.g. scale ups, addition of new technologies.
* Co-ordinate Japanese specific requirements (co-ordination of the Site Accreditation and notification to JPKK, co-ordination of Consistency Checks in accordance with required timelines and co-ordination and/or support of Japan BQ inspections).
* Support Regulatory QA Team Lead/Quality Management to plan, complete and front load workload.
* Attend local change control board and complete change control assessments, as required.
* Support Regulatory QA Team Lead in development of Regulatory and Project Strategies.
* Support Site Master File review and update.
Have You:
* Bachelor’s Degree in a Scientific/Technical discipline required
* A minimum of 3+ year's experience in a quality, manufacturing, validation or compliance role within biological and/or pharmaceutical industry.
* Up to date knowledge of relevant pharmaceutical Legislation, Directives and Regulations, in particular FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals.
* Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position.
* Previous experience working as a Regulatory Specialist.
* Post-graduate degree specific to Regulatory Affairs (Diploma/Masters).
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com
