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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

Director of Regulatory Affairs - Join a Leading Biotech Innovator!

Are you a skilled Regulatory Affairs professional with a passion for strategic impact? This is an incredible opportunity to step into a dynamic environment where your expertise will shape regulatory strategies and submissions for groundbreaking therapies in clinical development.

About the Role
As Director of Regulatory Affairs, you'll play a key role in leading US regulatory efforts, working across departments to develop submission strategies, manage timelines, and engage with health authorities. Reporting to the VP of Regulatory Affairs, you'll serve as a trusted advisor on regulatory requirements and submissions, making a significant impact in a fast-growing, cross-functional team.

Key Responsibilities

Lead US regulatory support across product lifecycles, ensuring compliance and strategy alignment.
Guide regulatory submissions, including INDs, clinical protocols, annual reports, and more.
Serve as the main interface with health authorities, providing regulatory guidance and insights.
Act as a US regulatory expert, advising on strategies and timelines while closely monitoring the regulatory landscape.

What You'll Bring

With a B.S. or M.Sc. in a scientific discipline and 7+ years in US Regulatory Affairs (preferably within biotech or pharma).
You'll have a proven track record in regulatory submissions and oncology experience.
As a collaborative and detail-oriented professional.
You thrive in complex environments and bring exceptional communication and relationship-building skills.
If you're agile, adaptable, and excited by the chance to drive regulatory strategy for a leading biotech company, we'd love to connect!

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.

INDRA

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