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.

Job Description

The Director of Regulatory Operations is responsible for ensuring the smooth daily operations across large, multi-faceted brands or entire accounts. This role manages a team of direct and indirect reports, from Associates to Senior Managers, including making hiring decisions, overseeing onboarding, and fostering career development. The Director partners with clients to uncover, document, or improve Medical, Legal, and Regulatory review processes, advising them on how to streamline submission and review procedures. Additionally, they inform staffing forecasts and provide guidance on program or account-level scopes. As an active participant in strategic discussions with clients, the Director is adept at driving difficult or complex submission discussions and facilitating resolutions. They provide leadership, career guidance, and training opportunities for the Regulatory staff, ensuring the team's continued growth and effectiveness.

Create and/or provide oversight to the creation of high quality MLR submission packages, ensuring that all submission materials conform to internal, client-specific, and FDA guidelines.Manage multiple direct and indirect reports at the Associate through Senior Manager level, including responsibility for interviewing, hiring, onboarding, training, and career development.Coordinate the delegation of work among reporting staff to manage workflow across a book of business. Ensure appropriate resources are available across all workstreams to meet client deadlines.Partner with VP to create and distribute departmental SOPs.Create, update, and disseminate to department/team documentation on client specific guidelines.Establish solid, direct relationships with client MLR teams, acting as a primary point of contact and to ensure all submissions are received on time and meet all client expectations and specifications.Partner with client teams to optimize and improve the submission process, offer recommendations on best practices and drive process forward.Partner with other capability leads to constantly improve and refine internal process.Diagnose and effectively partner with other capability leads to address submission quality concerns.

 

Qualifications

Required

Minimum of a bachelor's degree and 7-9 years of experience in the preparation of complex submission deliverables under tight deadline constraintsExperience working in content management systems such as Veeva VaultCourageous leadership skillsTechnical competency in Adobe Acrobat and the Microsoft Office SuiteClear communication and attention to detailExperience communicating with clients directlyExcellent organizational skillsStrong presentation skillsExperience managing diverse direct reports and growing talent

 

Preferred

Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experienceExperience working with launch brandsClear, concise technical writing abilityWorking knowledge of Adobe InDesign and Photoshop

 

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

If you require accommodation or assistance with the application or onboarding process specifically, please contact [email protected]. 

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

Veterans Encouraged to Apply

#LI-Hybrid

Compensation Range:  $98,500 - $165,500 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. For this role, 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 7/26/2024.