Manager, Regulatory Operations

The Manager, Regulatory Promotional Operations is a subject matter expert specializing in the preparation of promotional materials to be submitted to our pharmaceutical clients’ Medical, Legal, Regulatory (MLR) review in accordance with both client specific standards and requirements as well as internal guidelines.

The Manager is responsible for tracking the progress of each project through the various stages of the MLR review process, as well as advising on submission timelines and resource requirements to ensure that the team is able to meet all submission deadlines. The Manager is also responsible for the delegation of projects across a team of direct and/or indirect reports at the Associate and Senior Associate levels.

The Manager plays a key role in establishing procedures for internal teams, as well as advising on specific projects to aid a smooth and fast review by client teams.

• Create and/or oversee the creation of the submissions and ensure they conform to both internal guidelines as well as client specific requirements.
• Manage one or more direct reports at the Associate and Senior Associate level, including responsibility for interviewing, hiring, onboarding, training, and career development.
• Determine the time and effort required to complete each submission.
• Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines.
• Follow up with client liaisons to ensure submissions are received on time and meet all client expectations and specifications.
• Create, update, and disseminate to department/team documentation on client specific guidelines.
• Advise Project Management team on submission timelines & resource requirements.
• Actively manage team expectations; directly interface with clients as required.
• Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage.
• Oversee work of reporting employee(s) on daily basis, providing advice on projects, and helping to address problems as they arise.

Required

• Minimum of a bachelor's degree and 4-6 years of experience in the preparation of complex submission deliverables under tight deadline constraints
• Commitment to leading by example
• Technical competency in Adobe Acrobat and the Microsoft Office Suite
• Experience communicating with clients directly
• Clear communication and attention to detail
• Top notch organizational skills
• Experience managing at least 1 direct report
• At least one year of experience in Pharmaceutical Industry, Healthcare, or similar environment

Preferred

• Agency and/or project management experience
• Experience working on cross-functional teams
• Clear, concise technical writing ability
• Working knowledge of Adobe InDesign and Photoshop

Desirable

• Experience working in content management systems such as Veeva Vault
• Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience

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.