Executive Director, Regulatory Affairs Strategist

Confidential

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 providing regulatory expertise and guidance to ensure the successful delivery of business objectives. This role involves 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. The Executive Director will also act as a thought partner, enabling the Head of Global Regulatory Affairs, and will be a trusted member of the Regulatory Leadership Team, interacting with global regulatory agencies and contributing to the development of a harmonized regulatory voice. Applicants must have a BS/BA in a relevant scientific field, with an advanced degree preferred, and at least 12 years of experience in the pharmaceutical/biotechnology industry, including a minimum of 8 years in regulatory affairs, particularly in the development phase. The role requires significant leadership experience in the preparation and negotiation of various regulatory submissions and a deep understanding of the therapeutic area marketplace and clinical development. The ideal candidate will have a proven track record of managing multiple projects, strong leadership and influencing skills, and a proactive, transparent working style. Effective communication, time management, and operational skills are essential, as is experience with electronic document management systems for regulatory deliverables.

Hiring Manager Title
Head of Regulatory Affairs

Travel Percent
Less than 10%

Functions

  • CEO/President
  • Non-Profit Management
  • Operations
  • General Management
  • Strategy
Confidential
Vacancy posted 3 days ago
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