Associate Director Global Regulatory Sciences - Oncology

Associate Director, Global Regulatory Strategy, Hematology/Oncology

Position Responsibilities as a Global and US Regulatory Lead

• In conjunction with the Team leader; develop global regulatory strategy in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives.
• Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions.
• Work with cross-functional groups to define and manage contributions to submissions.
• Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
• Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
• Participate in and/or lead regulatory interactions with FDA, as assigned.
• In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.

Skills/Requirements

• Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science).
• 4-8 years pharmaceutical industry experience; significant experience in regulatory affairs (e.g. 3-5 years).
• Thorough knowledge of the drug development process, IND and NDA process. Demonstrated experience in preparing FDA submissions.
• Strong experience with US Regulatory submissions and dossiers (e.g., INDs; NDAs).
• Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to details.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.
• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
• Experience applying project management techniques within teams. Experience in effectively managing meetings.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate.
• Some travel may be required.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Cambridge Crossing: $199,350 - $241,566 & Princeton - NJ - US: $173,350 - $210,058

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Wellbeing Support:
  Programs such as BMS Well-Being Account, BMS Living…