Director – Regulatory Promotional Operations

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.