Expiry Date: 20-01-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
We have 2 new Regulatory Affairs Senior Manager roles open for an expanding and highly successful Global Biopharmaceutical company where you will be working on primarily biologicals in development. What sets this company apart is how many Senior Managers have evolved into US Leads, then GRLs and the company, based on merit, promote this career path. This is a great opportunity to work on both early development and late stage programs for biological products (mAbs and ATMPs) although they do support specialty meds that are small molecule, in a role that offers great opportunities for development, a supportive leadership team, and a stable work environment.
We have multiple roles open available:
Candidates need to have at least 3 years’ regulatory affairs ideally within development or pre-approval and have had exposure to some of the following: Orphan Drug Designations applications, Paediatric Investigation Plans, IND’s, s/NDAs or NDA/BLA preparations, plus the ability to provide strategic roadmaps including timelines, feasibility assessments for nonclinical and clinical development, gap analyses and due diligence for product development.
To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to firstname.lastname@example.org or if you would like more information on the role, on 855-505-1382. I will support you throughout the interview and on-boarding experience.
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