Head of Regulatory Affairs job in Rockville, USA

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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

This vacancy has now expired. Please see similar roles below...

Head of Regulatory Affairs - Permanent - Fully remote

Proclinical is seeking a Head of Regulatory Affairs to lead strategic regulatory decisions for an innovative biotech portfolio.

Primary Responsibilities:

This role will be responsible for leading the strategic regulatory decisions for their cutting-edge portfolio. As a core member of the leadership team, the successful candidate will guide global regulatory pathways, oversee a growing team, and report directly to the c-suite. This role requires a hands-on leader who excels in dynamic environments, bringing both tactical execution and strategic insight.

Skills & Requirements:

10+ years of Regulatory Affairs experience in a biotech or pharma environment.
Oncology/Immuno-Oncology expertise required.
Strong knowledge of FDA and global regulations.
IND/BLA submission experience is an advantage.

The Head of Regulatory Affairs' responsibilities will be:

Lead strategic regulatory decisions for the biotech portfolio.
Guide global regulatory pathways.
Oversee and mentor a growing regulatory team.
Report directly to the c-suite.
Ensure compliance with FDA and global regulations.
Manage IND/BLA submissions.

Compensation:

$280,000 to $300,000 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.