Expiry Date: 25-10-2019
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory / Regulatory Affairs CMC Contractor NCEs, with some home working – Brussels
Location: Brussels, Belgium
I am seeking a Regulatory Affairs CMC Contractor to work on a line extension, new dosage form for a speciality pharmaceutical product accompanying a clinical study. You will work with the manufacturing and formulations project team to bring the dossier to final build and submit, then support global markets with their local registrations.
The company is a growing biopharma with a unique heritage and a strong presence in Brussels and Europe. Manufacturing is lead from Brussels. The Regulatory CMC team is focused on supporting a number of products and there is a good chance you will be renewed. The Regulatory CMC head is very supportive and you will be managed directly by an experience RA CMC Director who has a lot of experiences in NDA/MAA M2/3 submissions.
You will be an experienced CMC Regulatory Manager with a track record in working with CMC sub teams to co-author and build line extensions new dosage forms, or fresh MAAs and be available to start within the next 2-4 weeks.
To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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