**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, Regulatory Promotional Operations, is responsible for overseeing the daily operations within a therapeutic area, managing a large portfolio of multifaceted brands. This role includes managing a diverse team of direct and indirect reports, ranging from Associates to Senior Managers, with responsibilities for hiring decisions, providing comprehensive onboarding, and fostering career development.In this strategic leadership role, the Director partners with cross-functional and client teams to develop, document, and enhance the Medical, Legal, Regulatory (MLR) submission and review processes. They provide expert advice on streamlining submission and review procedures, ensuring efficiency and compliance.The Director is also responsible for staffing forecasts and providing guidance on program or account-level scopes. They actively participate in strategic discussions with clients, handling complex or challenging submission issues and facilitating effective resolutions.As a key leader, the Director provides career guidance, training opportunities, and ongoing support to the Regulatory staff, driving their continued growth and effectiveness within the team.**DUTIES & RESPONSIBILITIES:**+ Oversee the submission process for a large portfolio of multifaceted brands, ensuring alignment with client expectations and regulatory requirements. Manage the overall submission strategy and execution.+ Supervise the creation of high-quality MLR submission packages, ensuring they conform to internal standards, client-specific requirements, and FDA guidelines.+ Oversee a team of direct and indirect reports, including Associates, Senior Associates, and Managers. Responsible for hiring decisions, onboarding, training, career development, and providing leadership to support team growth.+ Collaborate with the VP, Regulatory Promotional Operations to create, update, and disseminate departmental Standard Operating Procedures (SOPs) and documentation on client-specific guidelines.+ Provide estimates for Statement of Work (SOW) development and advise the Project Management team on submission timelines and resource requirements.+ Build and maintain strong, direct relationships with client MLR teams, acting as the primary point of contact. Ensure timely receipt of submissions and alignment with client expectations and specifications.+ Work with cross-functional and client teams to optimize and improve the submission process, offering recommendations on best practices and driving process improvements.+ Diagnose and address submission quality concerns in collaboration with other capability leads to ensure the highest standards of work.+ Participate actively in strategic discussions with clients, handling complex or challenging submission issues, and facilitating resolutions. Provide leadership and guidance to drive the success of the submission process.**Qualifications**_Required_+ Bachelor’s degree in a relevant field and 6-8 years relevant experience preparing complex submission deliverables under tight deadlines.+ Technical competency in Adobe Acrobat Pro DC and Microsoft Office Suite.+ Proficiency in Veeva Vault PromoMats.+ Meticulous attention to detail.+ Superior organizational skills and ability to effectively manage multiple tasks efficiently.+ Exceptional communication skills and experience communicating with clients directly.+ Experience managing diverse direct reports and devotion to growing talent.+ Courageous leadership skills and a commitment to leading by example.+ Strong presentation skills._Preferred_+ Demonstrated knowledge of FDA regulations for promotional materials, gained through appropriate training or previous experience.+ Experience working with launch brands.+ Working knowledge of Adobe InDesign and PhotoShop.**Additional Information**_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.__Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.__All your information will be kept confidential according to EEO guidelines.__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 10/22/2024._
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Director, Regulatory Promotional Operations_