Senior Director Regulatory Affairs Job Description Template
Our company is looking for a Senior Director Regulatory Affairs to join our team.
- 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.
- 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.