Bristol-Myers Squibb Company

Global Regulatory Manager

Location
Princeton, NJ, United States
Posted
Jul 02, 2019
Ref
R1515992
Required Education
Masters Degree/MBA
Position Type
Full time
Responsibilities

In conjunction with Regulatory Strategists, coordinate the creation, review, approval and communication of global regulatory plans, and transmit to internal and external experts to execute the plan).

Serve as member of Global Regulatory Subteam. Support Regulatory Strategist in preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc).

Provide support for tracking progress and resolving strategic issues related to Clinical Trial Applications.

Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions.

Coordinate preparation of response to HA questions according to a rapid response process for assigned projects. Manage, track, review regulatory deliverables from external partners for regulatory deliverables.

Maintain and/or review tracking data in the Regulatory Information Management System

Coordinate regulatory communications required for regulatory actions to regional and local regulatory.

Experience

1+ year of experience working as a regulatory manager in the pharma industry or government agency, or related activity such as educational fellowship in regulatory sciences, or experience in clinical or medical manager role related to pharmaceutical development

Scientific background (i.e. desirable is MS in regulatory science, or MS or PharmD, in life sciences, chemistry, or pharmacy. Minimum requirement is BS in life sciences if accompanied by pharmaceutical regulatory experience of 3 or more years)

Demonstrates a high-level of self-motivation and professional commitment; able to work independently to deliver work accountabilities.

Excellent verbal and written communication skills.

Strong organizational skills, with ability to adapt and manage multiple projects at one time.

Competency with Microsoft Office Suite; able to learn and work in new software systems with appropriate training.

Comfortable working in a fast-paced environment where speed is paramount without compromising quality.

Ability to recognize, articulate, and communicate program risks under their accountability and escalate such risks. Willingness and ability to effectively cooperate and collaborate with all BMS functions and with external business partners.