Do you want your first Global Reg Lead role? NYC / New Jersey with Relocation

Reference: SMI522

Expiry Date: 16-01-2023

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

New York County
United States

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Job Description

I recently placed the team leader in this well-known global biopharmaceutical company, which has many firsts to their name. Their pipeline is expanding, and this is without a doubt one of the main three companies in oncology. As part of this expansion, we are hiring for a Global Regulatory Leader who wants to lead the regulatory strategy and RA sub-team, in a company where GRLs are Directors, and Directors are rewarded and incentivised well.

Their line manager is now building up the team of GRLs in Europe to lead NMEs in development and support new lifecycle.

The responsibilities of this role will include leadership of responsibilities for global regulatory strategy and serve as a team lead of marketing application submission teams, as well as helping to develop strategy and content for global dossiers. You will also support the preparation of key HA interactions and assure consistent positions on common issues are presented to global HA. Additionally, you will Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.

To apply for this role, you will have over 4 years of experience in Regulatory Affairs, a solid scientific background (Ph.D., M.D., PharmD, MS, or BS), and significant understanding of scientific content and complexities, as well as good knowledge of Oncology drug development. You will be a proactive team-player with good interpersonal and issue-resolution skills who understands strategic and tactical roles and deliverables of Global Regulator Strategy in the Product Development and Commercialization process. You will also possess knowledge of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies globally for drug development and approval.


To Apply!

To apply for this role, please contact Ivan Nash on +44 207 801 3388 or US 908 332 9157 or press the red “Apply for position” button or send me an email to and I will reply by return. I will support you throughout the interview and on-boarding experience.

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