Associate Director

Associate Director, GRS Heme/Onc 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 work 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. Responsibilities In conjunction with the Team leader, develop global regulatory strategy in development and through life cycle management taking into account 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 for compliant submissions. Work with cross‑functional groups to define and manage contributions to submissions. Participate in or lead the regional Regulatory Sub‑team for assigned product(s)/project(s). Write regulatory documents (e.g., new INDs, briefing book content, BTL designation request, Priority Review Requests, ODD); review core documents to support IND/BLA/NDA in conjunction with EUL or GRL as needed. Contribute to 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. Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science) and 4‑8 years pharmaceutical industry experience; 3‑5 years significant experience in regulatory affairs. 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). Interdependent partnering skills, team‑oriented and ability to influence outcomes. 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. 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 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 and managing meetings. Experience developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Demonstrated ability to facilitate issue resolution and conflict management, negotiate and influence others, drive quality decision making, organize and prioritize tasks, and negotiate. Demonstrated ability to coordinate global activities. Some travel may be required. Qualifications PhD, MD, Pharm.D., BS or MS in regulatory science or related field. 4‑8 years of pharmaceutical industry experience. 3‑5 years of significant experience in regulatory affairs with mandatory FDA submissions. Proven knowledge of mandatory regulatory submission processes (IND, BLA, NDA). Strong experience with US regulatory submissions and dossiers. Team‑building and influencing skills; ability to lead cross‑functional initiatives. Data‑driven analytical and problem‑solving abilities with independent decision making. Ownership mindset and results orientation. Excellent communication skills. Project‑management experience. Experience developing regulatory strategies aligned with clinical plans and marketing objectives. Travel flexibility. Compensation Overview Princeton - NJ - US: $173,350 – $210,058 on a full‑time employee basis. Additional incentive cash and stock opportunities may be available based on eligibility. Final individual compensation will be determined based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental and vision care. Well‑Being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Program (EAP). Financial Well‑Being & Protection: 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. Paid Time Off: Flexible time off policy with unlimited paid days (subject to manager approval) for US exempt employees and annual paid vacation for exempt/ non‑exempt workers in Phoenix, AZ and Puerto Rico. Unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement and military needs. Annual Global Shutdown between Christmas and New Year’s Day. On‑Site Protocol BMS determines onsite requirements based on role type: Site‑essential (100% onsite), Site‑by‑design (≥50% onsite), Field‑based or Remote‑by‑design (physical travel to customers, patients or partners as essential). Site personnel must participate in essential onsite activities. Supporting People With Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and ongoing support. Applicants may request accommodations prior to accepting a job offer. Contact View email address on click.appcast.io for assistance. Visit careers.bms.com/eeo-accessibility for the complete Equal Employment Opportunity statement. Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in the applicant’s area. Data Protection BMS will never request payments, financial information or social security numbers during the application or recruitment process. Learn more at careers.bms.com/fraud-protection. All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr