Senior Director Regulatory Affairs

Senior Director Regulatory Affairs Job Description Template

Our company is looking for a Senior Director Regulatory Affairs to join our team.

Responsibilities:

  • Provide project-specific regulatory support to resolve issues;
  • Liaise with the FDA and EMA as appropriate;
  • Manage, train and mentor regulatory affairs personnel;
  • Develop and maintain regulatory timelines for development programs and submissions;
  • Implement regulatory strategies for development programs and products;
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs;
  • Collaborate with global development partners;
  • Oversee the preparation of meeting requests and briefing documents, and the coordination and preparation of teams for health authority meetings;
  • Oversee the development and implementation of regulatory strategies by global regulatory leads and regional regulatory leads;
  • Oversee development and presentation of development strategies for governance milestones;
  • Performs other duties as required;
  • Maintain Regulatory records and files;
  • Review changes in international laws and regulations and assess their impact and make recommendations to ensure compliance;
  • Work with Marketing and others to develop compliant product labeling. Review and approve product labeling for compliance with regulatory requirements;
  • Review, evaluate and approve Document Changes, especially those concerning significant (from a regulatory perspective) changes and revisions.

Requirements:

  • Demonstrated leadership experience in regulatory affairs (Manager, Senior Manager, or Director level);
  • Strong understanding of the FDA and EMA regulations and drug development process;
  • Must be local to Wayne, PA to be considered for full time employment;
  • 8+ years of regulatory affairs experience in a research setting at a CRO or sponsor company;
  • Experience interacting with the FDA;
  • 5+ years of experience with IND submissions;
  • Bachelor’s degree in science field.