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Executive Director, Regulatory Affairs

Denver, CO, United States

Executive Director, Regulatory Affairs

About the Company

Pioneering developer & manufacturer of innovative therapeutic medicines

Industry

Biotechnology

Type

Public Company

Founded

1980

Employees

10,001+

Categories

Biotechnology

Biotechnology and Pharmaceuticals

Biotech

Health Care

Pharmaceutical

Pharmaceuticals

Academic Research

Manufacturing

Genomics

Therapeutics

Clinical Care

Patient Management

Healthcare

Life Sciences

Personalized Medicine

Medicine

Chemical Products

Specialties

Biologics

Human therapeutics

and Development of novel products

Business Classifications

B2C

Mobile

About the Role

The Company is seeking an Executive Director of Regulatory Affairs to join their team. This pivotal role involves leading and directing regulatory affairs activities within an assigned therapeutic area, ensuring compliance with global and regional laws and regulations. The successful candidate will provide strategic leadership to the regulatory affairs team, oversee the development of regulatory strategies, and engage in effective interactions with regulatory agencies. Responsibilities also include providing regulatory expertise to commercialization teams, contributing to the development of global and regional product labels, and influencing the regulatory legislative environment in line with the company's policy priorities. The role requires a strong leader with the ability to manage and mentor staff, champion change, and foster a culture of continuous improvement.Candidates for the Executive Director of Regulatory Affairs position at the company should have a Doctorate, Master's, or Bachelor's degree in a relevant field, along with a significant amount of experience in regulatory affairs and at least 6 years of managerial experience. The ideal candidate will have a proven track record of leading teams, excellent communication skills, and the ability to understand and communicate scientific and clinical information effectively. They should be adept at setting organizational direction, anticipating strategic issues, and resolving conflicts to achieve positive outcomes. The role demands a leader who can inspire and empower their team, accelerate progress in line with patient needs, and integrate the company's resources to drive results.

Hiring Manager Title

Senior Vice President Global Regulatory Affairs and Strategy

Travel Percent

Less than 10%

Functions

CEO/President

Non-Profit Management

Operations

General Management

Strategy

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