Manager Regulatory Review

Job Description

The Manager, Regulatory Review manages a team of Associates and Senior Associates to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical clients for regulatory review. You will contribute in establishing procedures for our teams and advising on specific projects to aid smooth and fast review by clients. You will report to the Director, Regulatory Promotional Operations.

This is a hybrid role, requiring three days in-office each week. If you are contacted for an interview, your recruiter will discuss specifics with you, inclusive of any necessary reasonable accommodations.

Your Impact:

Manage multiple direct reports at the Associate, Senior Associate, and Manager level including responsibility for interviewing, hiring, onboarding, and career development

Provide estimates for SOW development

Work with the Director, Regulatory Review in the development of departmental SOPs

Oversee work of reporting employees on daily basis, providing advice on projects, and addressing problems as they arise

Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage

Determine the time and effort required to complete each submission

Establish a timeline and assign responsibility to the appropriate team members for delivering the components of the submission

Oversee the creation of the components and ensure they conform to client and Digitas Health guidelines

Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines

Follow up with client liaison promptly to ensure the submission is received on time and meet 100% of client expectations and specifications

Maintain to the department procedure(s) specific to the clients supported