Vice President, Internal Medicine Regulatory Strategy
- Full-time
Vice President, Internal Medicine Regulatory Strategy
About the Company
Acclaimed manufacturer of biopharmaceutical products
Industry
Pharmaceuticals
Type
Public Company
Founded
1849
Employees
10,001+
Categories
- Health Care
- Biotechnology
- Medical
- Pharmaceuticals
- Drug Manufacturing & Research
- Healthcare
- Manhattan
- New York City
- Pharmaceutical
- Precision Medicine
- Manufacturing
- Chemical Products
Specialties
Business Classifications
About the Role
The Company is seeking a Vice President for Internal Medicine Regulatory Strategy. This senior leadership role is pivotal in providing strategic direction and expertise in global regulatory processes, particularly in the areas of metabolic disease, cardiovascular risk, diabetes, and cachexia. The successful candidate will be responsible for ensuring that regulatory input is effectively integrated into clinical development plans, with the ultimate goal of achieving approvals with optimal labels. This includes a strong focus on innovative pathways and a proven track record of successful regulatory achievements in the relevant therapeutic areas. The role also involves influencing regulatory policy, representing the company in scientific and regulatory activities, and partnering with various internal and external stakeholders to ensure high-quality and well-coordinated regulatory deliverables. Applicants for this role at the company should hold an advanced scientific degree (M.D., Ph.D., PharmD) with a minimum of 10 years' experience in drug, device, development, and / or commercialization, preferably with a focus on regulatory affairs. A deep understanding of global regulatory strategies, particularly in the cardiovascular, renal, and metabolic disease areas, is essential. The ideal candidate will have a significant background in chronic weight management and the GLP-1 landscape, with a proven ability to negotiate with global health authorities and influence external stakeholders. Strategic thinking, the ability to lead in a highly matrixed organization, and a commitment to the growth and development of colleagues are also key qualifications for this role.
Hiring Manager Title
Head, GRS
Travel Percent
Less than 10%
Functions
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