CK Group are recruiting for a CMC Regulatory Affairs Associate to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract.
Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites. The Location:
This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.Salary:
Up to €26.70 per hour, dependent upon experience.CMC Regulatory Affairs Associate Role:
This role will be responsible for the registration document(s) procurement, preparation and coordination. You will also serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.
- Registration document(s) procurement, preparation, coordination submission and archival.
- Coordinate legalisation and delivery of registration documents following the instructions provided in the request.
- Maintain tracking and organisation of documentation, including uploading in CSD tool or other document repository.
- Support the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintain and optimise relevant databases, tracking systems and document management processes to support the licenses.
- Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline).
- Candidates MUST have GMP site experienc , with some sort of regulatory experience.
- The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS).
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices.
For more information or to apply for this CMC Regulatory Affairs Associate position, please contact Natasha on +44 1438 870011 or email firstname.lastname@example.org, quoting job ref 48810.
It is essential that applicants hold entitlement to work in Ireland.