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Associate Director, Global Regulatory Lead (Oncology/Hematology)

Posted Jun 07
Full Time
Princeton, New Jersey

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Responsibilities

 

  • Develop global and/or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
  • Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities
  • 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
  • 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
  • Provide strategic direction (and content input) on US Labeling
  • Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result.
  • Foster positive relationships with FDA.
  • Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
  • Interact routinely and will develop a strong team environment with colleagues throughout GRS

Degree Requirements

Minimum of Bachelors degree required; PhD, MD, PharmD, MS or commensurate experience preferred

Experience Requirements

Significant experience in regulatory affairs (e.g. 3-5 years)

Required

Key Competency Requirements

 

  • Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA for drug development and approval.
  • Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
  • Direct experience in developing strategy and leading teams through interactions with FDA.
  • Extensive experience in initiating and conducting successful interactions within FDA.
  • Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals

Other Qualifications

 

  • 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
  • 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.

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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Responsibilities

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.