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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