Executive Director, Regulatory Affairs

About the Company

Prominent clinical-stage biopharmaceutical company

Industry
Pharmaceuticals

Type
Public Company

About the Role

The Company is seeking an Executive Director of Regulatory Affairs with a focus on strategic and operational leadership. The successful candidate will be responsible for providing mentorship on general regulatory strategies, requirements for clinical studies, and marketing approval in domestic and international markets. This role involves critical issue management, advice on regulatory interactions, and overseeing the preparation and submission of regulatory documentation. The Executive Director will also be tasked with maintaining awareness of the global regulatory environment, integrating regulatory expertise with business knowledge, and ensuring that the company's regulatory processes are in line with industry standards.Candidates for this position should have a PhD with at least 10 years' experience in pharmaceutical regulatory affairs, or a B.S/M.S. with over 12 years in biotech or pharmaceutical regulatory affairs. The ideal candidate will have a proven track record of significant regulatory accomplishments, including experience with INDs/CTAs, BLAs/MAAs, and lifecycle management. Strong leadership, interpersonal, and negotiation skills are essential, as is the ability to work effectively in a global, cross-functional team. The role requires a professional with a very strong strategic acumen, the ability to balance short-term and long-term goals, and a talent for creative problem-solving. The Executive Director will also be expected to manage a regulatory team, build partnerships with key stakeholders, and ensure that the company's regulatory strategies align with its business objectives.

Travel Percent
Less than 10%

Functions

• CEO/President
• Non-Profit Management
• Operations
• General Management
• Strategy