Manager, Regulatory Affairs (MLR Coordinator)

The Position

The Regulatory Affairs MLR Manager is responsible for managing the MLR review and approval process. The Manager will schedule review meetings with the U.S. MLR team as well as the Commercial and Medical Affairs team to ensure timely review, discussion and approval of non-promotional and promotional materials. The manager is responsible for sending out a review meeting agenda of materials to be reviewed prior to the MLR meeting. During the review meetings, he/she will capture all recommended revisions in Veeva and coordinate with the material owner making the revisions to each reviewed item. The manager is responsible for ensuring processes for the review and approval of documents within Veeva are followed and that MLR timelines are met. They will also be responsible for tracking global MLR review materials and coordinating with the global MLR team and their corresponding vendors.

Responsibilities

• Act as the primary day-to-day liaison with the MLR reviewers, commercial, med affairs and assigned content owners.
• Schedule standing and ad hoc MLR review meetings with an agenda sent prior to the meeting.
• Work with material owner to ensure documents submitted for MLR review in Veeva are ready for review (document is complete, references are provided and annotated as appropriate). Liaise with and guide marketing agencies and document owners on the MLR submission standards.
• Conduct quality checks of materials submitted for MLR review for completeness and proof the final versions of approved materials for accuracy and completeness relative to MLR requested modifications.
• Facilitate regular live meetings with the review committee, electronically capture all MLR comments/revisions and provide these to the material owner in Veeva.
• Follow-up to obtain required approvals, signatures and comments from MLR reviewers
• Develop and maintain tracking sheets for all materials planned for MLR review.
• Notify material owner once a document is approved for use.
• Notify Information Technology to add / deactivate users in Veeva, manage workflows by cancelling or modifying tasks, upload documents/redlines from MLR meeting, remove expired documents
• Ensure FDA submission required documents are compiled and submission ready in a timely manner; prepare FDA Form 2253.

Requirements:

• Bachelor’s degree in Biochemistry, Chemistry, Biology, or related science discipline
• 7 years of relevant experience in pharmaceutical drug development 
• 5 years in regulatory affairs in supporting/coordinating MLR review 
• Demonstrable experience in successfully developing and managing regulatory submissions,
• Exceptional organizational skills, ability to multi-task and be detail oriented
• Strong interpersonal and communication (both oral and written)
• Works well within diverse groups to achieve common goals
• Ability to maintain highest degree of professionalism, integrity and diplomacy
• Strong problem-solving skills and ability to deal with changing priorities
• Excellent project management skills
• Proficient in pertinent software & tools (Veeva MedComms and Promomats)

Preferred: 

• Regulatory Affairs Certification through the Regulatory Affairs Professional Society is
• Prior experience with the preparation of regulatory submissions, as well as knowledgeable with FDA guidelines relevant to advertising and promotion compliance with marketed products
• Knowledgeable in industry trends for regulatory submission preparation, including electronic document submissions (i.e., eCTD)