Director, Regulatory Operations

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 peoples 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.

The 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.

• 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

• Minimum of a bachelors 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.

Our Publicis Groupe motto Viva La Différence means were 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

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

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