The Role
PE Global are recruiting for a Regulatory Affairs Associate for our biopharmaceutical client based in Dun Laoghaire, Dublin. This is a 12 -month contract role. Hybrid working options.
Job Responsibilities
- 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, with regulatory experience
- An understanding of regulatory filings
- 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****
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