Manager/Senior Manager, Global Regulatory Science CMC (Device and Combination Products)
- New Brunswick, NJ
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.
Position Summary / Objective
The GRS-CMC Manager/Senior Manager will act as subject matter expert (SME) focused on Regulatory-CMC device and combination product guidelines and regulations, providing strategy and support to project teams and GRS-CMC project leads. The position may include developing and coordinating relationships with Notified Bodies in Europe.
The Manager/Senior Manager will provide guidance to teams for the device/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 Manager/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.
TheCMC Manager/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, and in collaboration with the GRS-CMC project leads.
In addition to information in the position summary, the GRS-CMC Manager/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/Combo 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 teamsinsight into regulatory health authority expectations.
- Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success.
- Ensure the necessary updates are provided to team leaders (CMC Team Lead, Global Regulatory Team Lead, Line manager, etc.)
Degree/ Experience Requirements
- Manager - 3-5+ years pharmaceutical or related experience (min BA/BS). 2+ years CMC regulatory or related experience. Senior Manager - 4-6+ years pharmaceutical or related experience (min BA/BS). 4+ years CMC regulatory or related experience
- Device and/or combination product related experience
- Knowledge of CMC regulatory requirements during development and post-approval phases, with emphasis on devices and combination products.
- 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.
- Strong oral and written skills
- Proficient with electronic systems
- Occasional 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.
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 any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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