天涯社区官网

Director, Global Regulatory Affairs

US$235000 - US$250000 per annum
  1. Permanent
  2. Senior/Director & VP
  3. United States
Maryland, USA
Posting date: 03 Oct 2024
62572

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Director of Global Regulatory Affairs - Permanent - Maryland, US

天涯社区官网 is seeking a Director of Global Regulatory Affairs, Development Strategy to lead the U.S. regulatory strategy for innovative products targeting unmet medical needs and rare diseases.

Primary Responsibilities:

In this key role, the successful candidate develop and implement regulatory strategies, manage U.S. submissions, and collaborate with cross-functional teams to ensure smooth product lifecycle management.

Skills & Requirements:

  • Expertise in FDA submissions and regulatory policy.
  • Strong project management skills.
  • Experience in cell and gene therapy is a plus.
  • Ability to work collaboratively with cross-functional teams.
  • Excellent communication and organizational skills.

The Director of Global Regulatory Affairs' responsibilities will be:

  • Develop and implement U.S. regulatory strategies for innovative products.
  • Manage U.S. regulatory submissions and interactions with the FDA.
  • Collaborate with cross-functional teams to support product lifecycle management.
  • Provide regulatory guidance and expertise to internal teams.
  • Monitor and interpret regulatory policies and guidelines.
  • Participate in regulatory meetings and advisory committees as needed.

Compensation:

  • $235,000 to $250,000 per annum

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com

天涯社区官网 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

天涯社区官网 Staffing is an equal opportunity employer.

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