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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

Senior Director, Regulatory Solutions - Permanent -New Jersey (REMOTE)

��Ƶ is seeking a dynamic leader for the role of Senior Director, Regulatory Solutions.

Primary Responsibilities:

The successful candidate will focus on driving global regulatory strategy and ensuring compliance with major health agencies. You will lead a team to deliver successful regulatory submissions and provide expert guidance in the field of immunology and infectious diseases.

Skills & Requirements:

Proven experience in regulatory affairs with leadership capabilities.
Expertise in global regulatory submissions and eCTD processes.
Strong knowledge of FDA, EMA, and MHRA regulations.
Proficiency with regulatory intelligence tools and project management software.
Excellent communication, leadership, and strategic thinking skills.

The Senior Director, Regulatory Solutions' responsibilities will be:

Develop and implement global regulatory and product development strategies.
Lead and mentor a team to ensure adherence to regulatory standards.
Oversee the preparation and submission of regulatory filings such as IND, NDA, MAA, and ANDA.
Advise on regulatory pathways, clinical trial design, and approval strategies.
Monitor regulatory trends and proactively manage potential risks.
Manage cross-functional teams to ensure high-quality project execution.
Build and maintain strong client relationships to support business growth.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com

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

��Ƶ Staffing is an equal opportunity employer.

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