Senior Manager/Associate Director, Global Regulatory Sciences - CMC Devices and Combination
- Bristol Myers Squibb Company
- Summit, New Jersey
- Start date
- Mar 10, 2023
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Best Places to Work
Working with Us
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 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 rich in diversity. 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
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 regardingdrug products.
Position Summary / Objective
The GRS-CMC Global Senior Manager/Associate Director 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/Associate Director 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/Associate Director 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 Senior Manager/Associate Director 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/Associate Director 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 teamsinsight 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. Associate Director - 7-10+ years medical device, pharmaceutical or related experience (min BA/BS in Engineering, Pharmacy or related discipline). 6+ 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
The starting compensation for this job is a range from $143,874.00 - $169,263.00, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.
Final individual compensation will be decided based on demonstrated experience.
For more on benefits, please visit our https://careers.bms.com/working-with-us.
Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.
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.
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 an inclusive culture, promoting diversity 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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it 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.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
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