CMC Regulatory Affairs Associate in Dun Laoghaire, Ireland

  • Salary: Up to €34 per hour
  • REF Number: 00045612
  • Consultant: Natasha Young
  • Contact: 01246 457739
  • Date Published: 24.05.2019
  • Closed Date: 17.07.2019
  • Sector: Non-Specific
  • Location: Ireland (Dublin area)
  • Discipline: Regulatory Affairs

CK Group is 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 basis.

The Company: 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.

The Role: This role will support the coordination, development and/or execution of CMC regulatory registration activities in accordance with commercialization strategies and global regulatory plans. The successful candidate will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation. This role works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.

Key Responsibilities:

  • Registration document(s) procurement, preparation, coordination submission and archival.
  • Coordinate legalization and delivery of registration documents following the instructions provided in the request.
  • Maintain tracking and organization 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.
  • Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.

Your Background: To succeed in this role you will hold a degree in a Regulatory, Life Sciences, Biotechnology or related discipline, or equivalent working experience. You will have knowledge of Good Manufacturing Practices (GMP) and good documentation practices and at least basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS).

For more information or to apply for this position, please contact Natasha on 01246 457739 or email Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45612 in all correspondence.

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