OverviewThe Director, Regulatory Operations is responsible for ensuring the smooth daily operations of the team of employees who submit materials for regulatory review by external clients. The Director also supports teams with managing their clients' review processes including participation in client planning and presentations. Internally, the Director is responsible for continuous process improvement in guiding materials through review and ensuring awareness of changing regulatory environment. The Director is responsible for ensuring the entire department has the support required to complete their work. They must be a creative problem solver with projects and with their team. They are also responsible for identifying any potential pitfalls or challenges and ensuring they are escalated to senior leadership in a timely manner.
Responsibilities- Provide leadership, career guidance and training opportunities for the department staff
- Manage multiple direct reports at the Senior Manager, Manager, Associate and Senior Associate level including responsibility for interviewing, hiring, onboarding, and career development
- Manage workload across regulatory review departmen
- Work with staffing, recruiting, and individual business managers to determine workload projections to ensure all client needs are met
- Escalate potential large issues and concerns to senior leadership
- Work with external clients to establish appropriate regulatory review procedures where procedure has previously been lacking
- Advise external clients on streamlining their reviews
- Work with new external clients to uncover and document their review procedures
- Contribute to new business development efforts
- Train personnel on FDA regulations and the MLR review process
- Serve as an advocate for the Regulatory Review Department internally and in front of external clients
Qualifications- Minimum of a bachelor's degree and 6-9 years of experience in the preparation of complex deliverables under tight deadline constraints is required with at least 3 years of management experience.
- Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous pharmaceutical industry or healthcare experience is required.
- Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required.
- Extensive experience communicating with and presenting to clients is required. Clear communication and attention to detail are essential.
- Clear, concise technical writing ability is strongly preferred.
- At least 5 years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required.
Additional informationPublicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.
#LI-JS7
Compensation Range: USD $106,780.00 - USD $170,937.00/Annually. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. Temporary roles may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off. The Company anticipates the application deadline for this job posting will be 10/1/2026.
