Job Reference: JO-2109-65963_1631192567
A contract role has come up for one of our clients based in South Dublin. The organisation is a Globally renowned pharmaceutical organisation.
In this role, the successful candidate will support with CMC regulatory registration activities and support the companies' commercial strategies global regulatory plans
The Associate Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination.
- 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.
- Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
- Excellent written and verbal skills
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
- Strong written and oral communication skills
- The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
- Proficient use of MS Office tools, SharePoint and strong computer aptitude.
- Must have the ability to work within a team environment, but maintain a level of autonomy for managing daily tasks and activities
- Solid working knowledge of document management systems such as Documentum.
Education & Experience
Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline)
Candidates MUST have GMP site experience, with some sort of reg experience
Candidate needs to Regulatory filings at least
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