Associate Director of Regulatory Affairs Job at EPM Scientific, Bridgewater, NJ

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  • EPM Scientific
  • Bridgewater, NJ

Job Description

A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval compliance for a diverse portfolio of pharmaceutical products. This is a unique opportunity to join a purpose-driven organization focused on delivering better health outcomes through innovation, collaboration, and regulatory excellence.

The Associate Director main responsibilities will be…

  • Develop and implement regulatory strategies for assigned BRANDED/PRESCRIPTION pharmaceutical products, including NDA, ANDA, BLA, OTC, and device categories.
  • Serve as a regulatory lead on cross-functional product development and life-cycle management teams.
  • Ensure timely and accurate preparation of regulatory submissions and responses to health authorities.
  • Collaborate with global regulatory counterparts to ensure regional compliance and integration into product strategies.
  • Support the development and maintenance of compliant product labeling in coordination with labeling leads.
  • Act as a primary contact with regulatory agencies and support inspections and audits.
  • Provide regulatory input for business development and due diligence activities.
  • Contribute to annual planning and budgeting for regulatory activities.
  • May manage or mentor junior regulatory staff.

The Associate Director must have the following qualifications:

  • Bachelor's degree in a science or health-related field required; advanced degree preferred.
  • Minimum of 6 years of regulatory affairs experience in the pharmaceutical industry, with strong knowledge of BRANDED/PRESCRIPTION product regulations.
  • Experience across the product life-cycle, including development, labeling, advertising/promotion, and compliance.
  • Familiarity with domestic and international regulatory frameworks.
  • Ability to interpret and apply regulatory guidance to product strategy and documentation.
  • Regulatory Affairs Certification (RAC) is a plus.

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