Associate Director Global Regulatory Sciences - Oncology

Bristol Myers Squibb•Princeton, NJ

2d•$173,350 - $241,566•Hybrid

About The Position

Bristol Myers Squibb is seeking an Associate Director, Global Regulatory Strategy, Hematology/Oncology. This role involves developing global regulatory strategies for drug development and lifecycle management, considering guidance, commercial needs, and company objectives. The position requires leading regulatory dossier submissions to global authorities and the FDA, ensuring quality controls for compliant submissions. It also involves working with cross-functional groups to manage contributions to submissions, writing regulatory documents, and responding to Clinical Trial Application (CTA) queries. The role includes participating in and/or leading regulatory interactions with the FDA and developing global submission and Health Authority interaction plans in collaboration with the global regulatory team.

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.

Nice To Haves

Some travel may be required.

Responsibilities

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.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time.
Up to 2 paid volunteer days per year.
Summer hours flexibility.
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.