Director of Global Regulatory Affairs Strategy - Confidential : Job Details

Director of Global Regulatory Affairs Strategy

Confidential

Job Location : San Diego,CA, USA

Posted on : 2025-08-05T08:20:08Z

Job Description :

Director of Global Regulatory Affairs Strategy

About the Company

A leading biopharmaceutical organization recognized globally for its innovative solutions.

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
  • pulmonary

Business Classifications

  • B2B

About the Role

We are looking for a dynamic Director of Global Regulatory Affairs Strategy to join our international team. In this influential role, you will spearhead the development of comprehensive global regulatory strategies across our product portfolio, from initial stages through to approval and beyond. Collaborating closely with the Head of Regulatory Affairs and the Global Regulatory leadership team, you will leverage your deep understanding of regulatory frameworks, policies, and agency expectations.

As a strategic partner, you will provide essential regulatory insights and perspectives, facilitating cross-functional decision-making and enhancing our regulatory strategies for product development and lifecycle management. The ideal candidate will possess a BS/BA in a relevant scientific discipline, with an advanced degree preferred, and a minimum of 12 years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs.

Key qualifications include significant leadership experience, strong negotiation skills, and a proven ability to manage complex, multifaceted projects. You should be skilled in fostering relationships and building networks, with a proactive and transparent approach to your work. Additionally, your capabilities in conducting expert analyses and providing recommendations on regulatory risks, pathways, and policy shifts will be essential in this role.

Hiring Manager Title Head of Regulatory Affairs

Travel Percent Less than 10%

Functions

  • Medical Care/Hospital Administration
  • Non-Profit Management
Apply Now!

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