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Bristol-Meyers Squibb, Co.

Director, Global Regulatory Biologics CMC (R1547114-en-us)

Pharmaceuticals

All

Yearly

No

Princeton, New Jersey, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.

Oversee management of development and life-cycle projects of varying priorities and complexities. Represent GRS-CMC on cross functional teams and due diligence /in-licensing projects. Participate and/or provide input for governance committee reviews related to their groups projects. Lead and/or actively participates in departmental and/or cross function initiatives. Represent BMS at health authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develop & communicate strategic direction based on global regulatory guidelines and experience. Seek opportunities for external regulatory engagement for themselves and/or members of their team.

In addition to the general objectives, the GRS-CMC Director is responsible for the following:

  • Develop & 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 managers 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.

Requirements:

  • Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience.

  • Knowledge of CMC regulatory requirements during development and post-approval phases.

  • Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently..

  • Ability to interact with CMC technical experts regarding process development and analytical issues.

  • Ability to identify, communicate and resolve routine/complex issues.

  • Ability to identify trends & changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

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