Title: Senior Associate Regulatory Affairs
Location: Dun Laoghaire
Senior Associate Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination. The Associate Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation. Works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.
- 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 other 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.
Education and Experience:
- Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology, or related discipline)
- Must have GMP site experience and regulatory experience
- Regulatory filing experience
- 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 ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
- Solid working knowledge on document management systems such as Documentum.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.