Executive Director, Regulatory Affairs Liaison
Confidential
Executive Director, Regulatory Affairs Liaison
About the Company
Industry shaping pharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1891
Employees
10,001+
Categories
- Biotechnology
- Health Care
- Medical
- Pharmaceuticals
- Biotechnology and Pharmaceuticals
- Drug Manufacturing & Research
- Healthcare
Specialties
- pharmaceutical
Business Classifications
- B2C
- E-Commerce
About the Role
The Company is seeking an Executive Director, Regulatory Affairs Liaison with a focus on ophthalmology programs. The successful candidate will be responsible for defining and executing global regulatory strategies for these programs, ensuring alignment with development, evidence-generation, and commercialization priorities. This leadership role involves overseeing a team of Global Regulatory Leads, setting standards for regulatory excellence, and serving as an authoritative expert in ophthalmology drug development. The Executive Director will also be accountable for minimizing time to approval and optimizing labeling for multiple indications, as well as representing the company in external engagements with major health authorities. Applicants must have a B.S./M.S. in biological science or a related discipline with a minimum of 12 years of relevant drug development experience, or an M.D./Ph.D. or PharmD. with a minimum of 9 years of relevant drug development experience. A significant portion of this experience should be in regulatory affairs, with a proven track record of securing original NDA/BLA approvals. The role requires outstanding interpersonal, communication, and negotiation skills, as well as demonstrated leadership attributes and the ability to build and lead high-performing teams. Preferred qualifications include regulatory experience in retinal disease and ophthalmology programs, people management experience, and substantial experience with both small and large molecule development programs. The candidate should be adept at strategic thinking, and resource allocation, and have a thorough familiarity with worldwide regulatory agencies.
Hiring Manager Title
Vice President (VP), General Medicine
Travel Percent
10%
Functions
- Operations
$231.9k - $365k
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