Director, Regulatory Operations

RiseMe; New York (NY); On-site; USD 107,000 - 171,000; Full time

Job summary

CoLab, a unit within Publicis Groupe, seeks a Director of Regulatory Operations to lead the team responsible for submitting materials for regulatory review for external clients. The role emphasizes process improvement, timely delivery, and adherence to FDA advertising regulations.

You will mentor staff at multiple levels, coordinate workload, manage client interactions, and help streamline review procedures while identifying risks and escalating issues to senior leadership.

Qualifications

• Bachelor's degree required with 6–9 years in complex deliverables.
• Minimum 3 years of management experience.
• Experience with FDA pharmaceutical advertising regulations.
• Strong written and oral communication; attention to detail.
• Experience in Pharmaceutical Industry, Healthcare, or Advertising Agency.

Responsibilities

• Provide leadership and career development for department staff.
• Manage multiple direct reports at varied levels.
• Oversee workload across regulatory review department.
• Coordinate with staffing to meet client needs.
• Escalate issues to senior leadership as needed.
• Advise clients on regulatory review procedures.
• Contribute to new business development.
• Train staff on FDA regulations and MLR process.
• Advocate for Regulatory Review internally and externally.

Skills

Leadership

Regulatory knowledge

FDA regulations

Client communication

Project management

Microsoft Office

Writing

Education

Bachelor's degree

Tools

Internet Explorer

Adobe Acrobat

Microsoft Office

Job description

Company Description

CoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people’s lives by connecting real-time data with world-class creative, content, and media in service of growth and Return on investment.

CoLab is a “power of one” solution, encompassing data, media, and production. By drawing from across the vast Publicis Groupe network, we are uniquely positioned to deliver innovation and specialized skills to our clients, as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the atmosphere of a startup company with the stability and experience of a global leader.

Overview

The Director, Regulatory Operations is responsible for ensuring the smooth daily operations of the team of employees who submit materials for regulatory review by CoLab's 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 throughout CoLab 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 department
• 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 DH personnel on FDA regulations and the MLR review process
• Serve as an advocate for the Regulatory Review Department internally and in front of external client

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.

Note: This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Performs other duties (or functions) as assigned.

Additional Information

Our Publicis Groupe motto “Viva La Différence” means we’re better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent.

Publicis 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.

If you require accommodation or assistance with the application or onboarding process specifically, please contact [e-mail].

All your information will be kept confidential according to EEO guidelines.

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 9/28/2026.