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 Vice President, Director of Regulatory Operations, acts as the lead for a large-scale portfolio or business/therapeutic unit. This role is responsible for managing a team of staff, from Associate through to Director levels, ensuring that promotional materials for Medical, Legal, and Regulatory review are submitted in accordance with client-specific guidelines and FDA requirements. With deep industry knowledge, the VP is a visible team leader who creates high-value training materials. This individual is a collaborative partner who works with cross-capability leads to establish best practices and standardized processes and ways of working. The VP is skilled at diagnosing and effectively partnering with other capability leads to address submission quality concerns. The VP establishes solid, direct relationships with clients and partner with them to develop or refine Medical, Legal, Regualtory review processes. Additionally, the VP demonstrates the ability to grow the Regulatory Operations team's talent, ensuring the team’s continued development and success.

• Provide oversight to the creation 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 Director level, including responsibility for interviewing, hiring, onboarding, training, and career development.
• Coordinate the delegation of work among reporting staff to manage workflow across a large scale portfolio or business/therapeutic unit. Ensure appropriate resources are available across all workstreams to meet client deadlines.
• Develop 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