Senior Manager, Global Regulatory Sciences - CMC Devices and Combination Products
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.
Functional Area Description
The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of product lifecycle. Members of the organization develop global regulatory CMC strategies and collaborate with key stakeholders to execute the strategies in alignment with business priorities. The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for combination products, medical, and digital devices, oversees the TSE/BSE program and 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.
Position Summary / Objective
The GRS-CMC Global Senior Manager will act as subject matter expert (SME) focused on Regulatory-CMC medical device, digital, software, and combination product guidelines and regulations, providing strategy and support to project teams. The position may include developing and coordinating relationships with Notified Bodies in Europe.
The Senior Manager will provide guidance to teams for the medical device/digital/combination product related content of regulatory submissions including clinical trial applications, new marketing applications, HA responses, background packages and/or post-approval submissions, and will review relevant Quality Module sections of submissions.
The Senior Manager will collaborate with stakeholders across functional areas to develop/enhance business processes with an overall goal of ensuring regulatory compliance and efficient processes. The position may also include participation on due diligence/in-licensing projects.
The CMC Senior Manager will serve as the primary interface between the broader Global Regulatory organization and Global Product Supply (GPS) with regard to device/combination product aspects
In addition to information in the position summary, the GRS-CMC Senior Manager is responsible for the following:
Coordinate and/or develop and maintain relevant procedural documents, white papers and guidelines within GRS-CMC.
Support and communicate with project teams (e.g. CMC Team, Device/Combination Product Teams, GRS Team) with regard to technical issues that may affect regulatory submissions, strategy, or success.
Provide strategic CMC regulatory expertise for project teams.
Interpret global regulations and guidance and identify regulatory opportunities and risks.
Identify, communicate and propose resolution to routine/complex issues.
Provide technical teams insight into regulatory health authority expectations.
Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success.
Minimum BA/BS Degree
Senior Manager - 4-6+ years medical device, pharmaceutical or related experience (min BA/BS in Engineering, Pharmacy or related discipline). 4+ years CMC regulatory or related experience.
Medical device/software/digital and related combination product development experience preferred.
Knowledge of CMC regulatory requirements during development and post-approval phases, with emphasis on Medical device/software/digital devices
Demonstrated ability to develop/maintain strong working relationships, participate on and/or lead cross-functional teams, handle and prioritize multiple projects and work independently.
Ability to identify, communicate and resolve routine/complex issues.
Ability to interpret global regulations and guidance documents.
Key Competency Requirements
Strong oral and written skills
Proficient with electronic systems
Some travel required
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.
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