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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 CoLab's external clients. This role supports client review processes, drives continuous process improvement, and ensures the department has the necessary support to complete their work. The Director must be a creative problem solver and identify potential pitfalls.
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 and recruiting to meet client needs.
- Escalate potential issues and concerns to senior leadership.
- Establish appropriate regulatory review procedures with external clients.
- Advise external clients on streamlining their reviews.
- Uncover and document review procedures with new external clients.
- 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 with external clients.
Requirements
- Minimum of a bachelor's degree.
- 6-9 years of experience in preparing complex deliverables under tight deadline constraints.
- At least 3 years of management experience.
- Demonstrated knowledge of FDA pharmaceutical advertising regulations.
- Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite.
- Extensive experience communicating with and presenting to clients.
- 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.
Skills
- FDA pharmaceutical advertising regulations
- Internet Explorer
- Adobe Acrobat
- Microsoft Office Suite
- Client communication
- Client presentation
- Clear communication
- Attention to detail
- Technical writing
Experience Level
- 3 years of management experience
- 5 years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency
- 6-9 years of experience
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 that provides best-in-class services in a fluid and modular way.
- 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.
Equal Opportunity
- 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.
- All your information will be kept confidential according to EEO guidelines.