Associate Director/Director, Regulatory Affairs

Associate Director/Director, Regulatory Affairs - Permanent - Florham Park - New Jersey

Proclinical is seeking a strategic leader to drive regulatory initiatives for innovative antiviral treatments.

Primary Responsibilities:

The successful candidate will collaborate with cross-functional teams and regulatory authorities to develop and implement regulatory strategies that support global development goals. You will also manage submissions, compliance, and post-marketing activities, ensuring successful transitions from early development to commercialization.

Skills & Requirements:

• Bachelor's degree in life sciences or related field (advanced degree preferred).
• 7+ years (Associate Director) / 10+ years (Director) of regulatory experience, preferably in antiviral products.
• Strong knowledge of FDA and ICH guidelines.

The Associate Director/Director, Regulatory Affairs' responsibilities will be:

• Develop and execute regional regulatory strategies.
• Collaborate with cross-functional teams and regulatory authorities.
• Lead regulatory submissions, updates, and ensure compliance with guidelines.

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.