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Associate Director/Director, Regulatory Affairs

Proclinical
Florham Park, NJ Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 4/23/2025

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.
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