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About the Role

The Director, Regulatory Operations is responsible for ensuring the smooth daily operations of the team that submits materials for regulatory review by external clients. This role supports teams in managing client review processes, including client planning and presentations. The Director drives continuous process improvement, ensures awareness of the changing regulatory environment, and provides the department with necessary support. This role requires creative problem-solving for both projects and the team, and timely escalation of potential challenges to senior leadership.

Responsibilities

Provide leadership, career guidance, and training opportunities for department staff.
Manage multiple direct reports, including interviewing, hiring, onboarding, and career development.
Manage workload across the regulatory review department.
Determine workload projections with staffing, recruiting, and business managers to meet client needs.
Escalate potential large issues and concerns to senior leadership.
Establish appropriate regulatory review procedures with external clients where needed.
Advise external clients on streamlining their reviews.
Uncover and document review procedures with new external clients.
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 with external clients.

Requirements

Minimum of a bachelor's degree and 6-9 years of experience in preparing complex deliverables under tight deadlines, 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.
Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite.
Extensive experience communicating with and presenting to clients.
Clear, concise technical writing ability is strongly preferred.
At least 5 years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency.

Skills

Leadership
Career guidance
Training
Management
Client communication
Client presentations
Process improvement
Regulatory knowledge (FDA)
Problem-solving
Technical writing
Microsoft Office Suite
Adobe Acrobat
Internet Explorer

Experience Level

6-9 years of experience
3 years of management experience
5 years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency

Education Level

Bachelor's degree

Salary/Compensations

USD $106,780.00 - USD $170,937.00/Annually

Benefits

Medical coverage
Dental
Vision
Disability
401K
Parental and family care leave
Family forming assistance
Tuition reimbursement
Flexible time off

About the Company

CoLab is a fully integrated, cross-discipline team providing best-in-class services in a fluid and modular way, focused on client growth and ROI by connecting real-time data with creative, content, and media.
CoLab offers a "power of one" solution encompassing data, media, and production, leveraging the Publicis Groupe network for innovation and specialized skills.
CoLab combines the atmosphere of a startup with the stability of a global leader.

Equal Opportunity

Publicis Groupe motto "Viva La Différence" emphasizes diversity and inclusion, fostering belonging and equitable experiences for all talent.
All information will be kept confidential according to EEO guidelines.