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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

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.

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