Quality , Science, Pharmaceutical & Food

Regulatory Affairs Associate – Dublin

  • Contract
  • Dún Laoghaire, County Dublin, Ireland
  • 41988584

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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