Job Description

Director - Regulatory Affairs

Location: Branchburg, NJ
Type: Direct Hire

We are partnering with a leading pharmaceutical company to identify a highly qualified Director of Regulatory Affairs to drive regulatory strategy, submissions, and collaboration across key functional teams. This position is critical for advancing the company's drug portfolio to ensure both regulatory compliance and commercial success.

Key Responsibilities

• Regulatory Leadership:

  • Provide strategic regulatory direction from product concept to market launch.
  • Guide development programs to meet U.S. and global regulatory standards.

• Collaboration:

  • Partner with R&D, Technical Operations, Clinical Development, and other departments to advance the drug portfolio.
  • Engage with stakeholders to shape and navigate new regulatory pathways.

• Compliance:

  • Oversee regulatory activities for 505(b)(1), 505(b)(2), and 505(j) pathways.
  • Ensure compliance with FDA and international regulatory requirements.

Qualifications

• Experience:

  • 7–12 years of regulatory experience in the pharmaceutical/biopharmaceutical industry.
  • Proven success in filing and obtaining FDA and international approvals.

• Knowledge:

  • Strong understanding of regulatory aspects across CMC, preclinical, clinical, and post-marketing phases.
  • Expertise in engaging with FDA and other global regulatory agencies.

• Skills:

  • Strategic mindset with demonstrated leadership in regulatory pathways.
  • Exceptional communication and cross-functional collaboration abilities.

Compensation and Benefits

• Salary Range: $197,500 - $224,750 per year.
• Full Benefits Package: Including health insurance and other standard benefits.

Why Join?

• Career Advancement: Opportunity to work with seasoned executives and lead pivotal regulatory initiatives.
• Impact: Drive strategic programs that directly contribute to commercial success.

Application Process

Executive Placement Network (EPN) is assisting our client in filling this position. EPN is a leading recruiting agency with a network of over 1,400 recruiters, specializing in executive search and client hiring needs.

Explore additional job opportunities at EPN Open Jobs

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