Working with UsChallenging. 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. 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. The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects. Represent BMS at Health Authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team.
Duties/Responsibilities:- Develop and communicate strategic direction based on global regulatory guidelines and experience
- Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness
- Review submissions from CMC Leads for clarity of both strategic and technical content
- Utilize electronic systems for dossier creation, review, and tracking
- Manage and actively support growth and development of direct reports
- Actively participates in leadership or department meetings
- Anticipate and communicate possible regulatory paradigm shifts
- Participate in product fact finding meetings and/or R&D forums representing GRS-CMCSupport the preparation of CMC policies and procedures
- Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes
Qualifications:
Qualifications Minimum BA/BS Degree Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience
Key Competencies:
Knowledge of CMC regulatory requirements for advanced therapies and/or and cell therapy during development and post-approval as applicable Knowledge of pharmaceutical development, including advanced therapies and/ or, biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products as applicable Ability to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independently Ability to interact with CMC technical experts regarding technical issues such as those related to process development and analytical Understanding of scientific content and complexities and good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration Experience leading cross-functional teams, demonstrated ability to drive quality decision-making and ability to organize / prioritize tasks Demonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict management Direct experience in developing strategy and leading teams through interactions with health authorities, track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components Strong understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment; looks for opportunities for continuous improvement Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies Communicates opinions, facts and thoughts with clarity, transparency, and honesty and sets clear and high expectations and holds self and others accountable for decisions and results achieved. Demonstrates ownership of results within (and beyond) area of responsibility Experience as a member of the CMC Team, GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions) Ability to broadly represent department functions on project team in a matrix organization Seeks multiple perspectives and listens openly to others' points of views Prior management experience preferred Proficient with electronic systems This position may require up to 5% of travel 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:
Brisbane - CA - US: $246,980 - $299,287 Cambridge Crossing: $246,980 - $299,287 Madison - Giralda - NJ - US: $199,950 - $242,297 San Diego - CA - US: $215,940 - $261,672 Seattle - WA: $219,950 - $266,523 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 Life Better, and Employee Assistance Programs (EAP).Financial Well-being and 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.
Work-life benefits include: Paid Time OffUS Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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 a supportive culture, promoting global participation 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 ProtocolBMS has an 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. Supporting People with DisabilitiesBMS 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. Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at .Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1602987 : Director, Regulatory CMC - Cell Therapy
Summary
Location:
Madison - Giralda - NJ - US; Cambridge Crossing; San Diego - CA - US; Seattle - WA - US; Bethesda - MD; Brisbane - CA
Type: Full time
