Director of Regulatory Operations

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.

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.

• 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

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.

Our Publicis Groupe motto “Viva La Différence” means we’re better together, and we believe that our differences make us stronger.…