Director, Global Regulatory Affairs

Director of Global Regulatory Affairs - Permanent - Maryland, US

Proclinical 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

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.