Regulatory Program Manager

You will be responsible for supporting the development and implementation of regulatory strategies to facilitate the development and approval of new drugs/biologics in the US, including monoclonal antibodies and other biotech products for use in oncology and endocrine diseases as well as other areas with significant unmet needs. You will serve as the primary liaison with regulatory authorities for the assigned projects and manage the strategy and execution of these interactions. Additional responsibilities include communication and teamwork with project team members across the globe, as well as development partners. You will be responsible for the communication and management of regulatory consultants, CROs, and other vendors.

You will represent Regulatory Affairs function on the Global Project Team and Regulatory Team. You will provide US specific regulatory input for development projects destined for the US market as directed and will offer operational regulatory support to preclinical and clinical efforts. You will liaise and network with the US regulatory agencies as necessary, to build working relationships with agency personnel as well as liaise and manage regulatory consultants, CROs, and other vendors.

You must have a Bachelor’s Degree in Life Sciences or Pharmaceuticals, (a Masters Degree or PhD in a clinical, health-related field or life sciences field is preferred). 5 years experience in Regulatory Affairs. including direct interactions with FDA is highly advantageous, as is specific experience with biotech development products. Oncology and/or endocrine experience is beneficial. You will have business knowledge and experience with US Regulatory Affairs and drug development, including development of regulatory strategy at the preclinical and clinical stages and knowledge of FDA processes from beginning to end.

Only candidates living and able to legally work in the US will be considered for this role.

How to apply for the Regulatory Program Manager role:

1. Click the button below to raise an email form
2. Attach your CV file to the email
3. Add any covering letter / personal notes to the body of the email
4. Send your completed job application through to us for processing.

Alternatively, for a confidential discussion concerning the Regulatory Program Manager opportunity you can telephone Nick LiBassi on +1 973 538 0444. Please be sure to quote 10374 in all correspondence relating to this role.