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.
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