Director of Regulatory Affairs

1 month ago

new york city, United States Arevna Full time

Director of Regulatory Affairs and Compliance - Women’s Health

Location: New Jersey


We’re seeking an experienced Director of Regulatory Affairs and Compliance to join a leading women’s health-focused organization based in New Jersey. In this role, you’ll drive regulatory strategies and compliance initiatives to support FDA approvals and maintain regulatory compliance across our innovative product portfolio.


Role Overview:

As the Director of Regulatory Affairs and Compliance, you will be responsible for guiding regulatory submissions and ensuring adherence to all U.S. regulatory requirements, particularly FDA standards. This key leadership position plays an essential role in product lifecycle management and supports the organization’s mission to improve women’s health outcomes.


Key Responsibilities:

  • Regulatory Strategy: Lead and execute U.S. regulatory activities, ensuring compliance for product marketing and safety.
  • Submission Leadership: Collaborate with cross-functional teams to design regulatory pathways and manage submission processes.
  • Compliance and Training: Oversee compliance programs, train internal teams, and conduct regular audits.
  • Risk Management: Identify and communicate compliance risks to senior management and recommend corrective actions.


Key Skills and Expertise:

  • Strong familiarity with U.S. FDA regulatory standards and requirements.
  • Exceptional interpersonal and communication abilities, including written, verbal, teamwork, leadership, organizational, and negotiation skills.
  • Regulatory Affairs (RA) certification from the Regulatory Affairs Professional Society (RAPS) is a plus.
  • Knowledgeable in manufacturing processes, project management, and continuous process improvement methodologies.
  • Proficient understanding of regulations, industry standards, and legal guidelines impacting the pharmaceutical industry, including the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act (FCPA), PhRMA Code, OIG Compliance Guidance, FDA Regulatory Guidelines, Federal Sunshine Act, state marketing disclosure laws, and state price reporting regulations.


Qualifications:

  • Experience: 10-15 years in U.S. regulatory affairs within pharma or medical devices, ideally in women’s health.
  • Education: Bachelor’s degree in a scientific field or engineering; advanced degree preferred.
  • Skills: Expertise in FDA regulations, strong leadership, and a solid understanding of relevant industry laws and compliance standards.
  • Preferred: Regulatory Affairs Certification (RAPS), experience with FDA submissions, and familiarity with continuous process improvement.


Why Join Us?

This role offers the chance to make a meaningful impact in women’s health through compliance excellence and regulatory leadership. We’re looking for a candidate who is passionate about advancing healthcare options for women and has the regulatory expertise to drive our vision forward.

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