Senior Director, Regulatory Solutions

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

Proclinical 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

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.