Executive Director, Regulatory Affairs Strategist

About the Company

Globally-recognized biopharmaceutical company

Industry Biotechnology

Type Public Company

Founded 1988

Employees 501-1000

Categories

Pharmaceuticals Medicine Manufacturing Chemical Products Biotechnology Biopharmaceuticals Biotechnology and Pharmaceuticals Drug Manufacturing & Research Healthcare Outsource Services Medical

Specialties

biotechnology orphan disease state pharmaceuticals chronic lung infections and pulmonary

Business Classifications

B2B

About the Role

The Company is seeking an Executive Director, Regulatory Affairs Strategist to join their global team. The successful candidate will be responsible for driving the formulation of global regulatory strategy across the portfolio, from early to late stage, and post-approval, in collaboration with the Head of Regulatory Affairs and the Global Regulatory leadership team. This role requires a strategic thinker with deep insight into regulatory frameworks, policies, and agency expectations, particularly from a government insider's perspective. The Executive Director will act as a thought partner, providing quality regulatory input and strategic perspective to internal business partners, and will help shape cross-functional decision-making to optimize the company's regulatory approaches for product development and lifecycle management.

Applicants must have a BS/BA in a relevant scientific field, with an advanced degree preferred, and at least 12 years of prior pharmaceutical/biotechnology experience, including a minimum of 8 years in relevant Regulatory Affairs. The role demands significant leadership experience, negotiation skills, and a proven track record of managing multiple intricate projects. The ideal candidate will be adept at building internal and external networks, leading negotiations, and will have a self-motivated, proactive, and transparent working style. Expert analysis and recommendations on regulatory risk, pathways, and policy shifts are also key requirements for this position.

Hiring Manager Title Head of Regulatory Affairs

Travel Percent Less than 10%

Functions

Medical Care/Hospital Administration Non-Profit Management