Associate Director/Director Global Regulatory Sciences - CMC Devices and Combination Products
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 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 regarding drug products.
Position Summary / Objective The GRS-CMC Associate Director/Director Devices and Combination Products will have primary responsibility for device and combination product strategy and related business processes.
The position may include direct report(s).
The Associate Director/Director will act as subject matter expert providing support to project teams and GRS-CMC project leads, and/or providing oversight of direct report(s) acting as such.
The Devices and Combination Products group will collaborate with stakeholders across functional areas to develop/enhance business processes with an overall goal of ensuring regulatory compliance and efficient processes.
The group will also participate on due diligence/in-licensing projects.
The Associate Director/Director will:
Represent GRS-CMC on cross-functional and governance committees and lead and/or actively participate in departmental and/or cross-functional initiatives aligned with business priorities.
Serve as a credible, respected spokesperson in discussions with key stakeholders.
Develop and communicate strategic direction based on global regulatory guidelines and experience.
Seek opportunities for external regulatory engagement for themselves and/or members of their team.
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.
Position Responsibilities In addition to information in the position summary, the GRS-CMC Associate Director/Director Devices and Combination Products is responsible for the following:
Coordinate and provide oversight/guidance to develop and maintain appropriate procedural documents, white papers and guidelines within GRS-CMC related to devices and combination products Provide oversight to subject matter experts (SMEs) focused on Regulatory-CMC device and combination product guidelines and regulations, including developing and coordinating relationships with Notified Bodies in Europe.
Develop and communicate strategic direction based on global regulatory guidelines and experience.
Work effectively with stakeholders to understand functional interdependencies, assess impact on effective processes, develop mutually agreed-upon optimized processes and drive key cross-functional initiatives and business imperatives Manage and actively support growth and development of direct reports.
Build strong trust-based relationships with stakeholders within the broader Global Regulatory organization, as well as Global Product Development and Supply (GPS).
Degree RequirementsMinimum BA/BS Degree Experience Requirements 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.
Director:
10
years medical device, pharmaceutical or related experience (min BA/BS in Engineering, Pharmacy or related discipline).
10
years CMC regulatory or related experience.
Medical device/software/digital and related combination product development experience Knowledge of CMC regulatory requirements during development and post-approval phases, with emphasis on combination products/medical devices/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 identify trends and changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary Key Competency Requirements Strong oral and written skills Prior management skills preferred Travel RequiredSome travel required #LI-Onsite CA Residents:
Associate Director:
The starting compensation for this job is a range from $164,000-$223,000, plus incentive cash and stock opportunities (based on eligibility).
Director:
The starting compensation for this job is a range from $223,000-$302,000, 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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.
On-site ProtocolPhysical 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.
BMS 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 email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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.
Recommended Skills Assessments Business Priorities Business Processes Clinical Trials Databases Due Diligence Estimated Salary: $20 to $28 per hour based on qualifications.
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 regarding drug products.
Position Summary / Objective The GRS-CMC Associate Director/Director Devices and Combination Products will have primary responsibility for device and combination product strategy and related business processes.
The position may include direct report(s).
The Associate Director/Director will act as subject matter expert providing support to project teams and GRS-CMC project leads, and/or providing oversight of direct report(s) acting as such.
The Devices and Combination Products group will collaborate with stakeholders across functional areas to develop/enhance business processes with an overall goal of ensuring regulatory compliance and efficient processes.
The group will also participate on due diligence/in-licensing projects.
The Associate Director/Director will:
Represent GRS-CMC on cross-functional and governance committees and lead and/or actively participate in departmental and/or cross-functional initiatives aligned with business priorities.
Serve as a credible, respected spokesperson in discussions with key stakeholders.
Develop and communicate strategic direction based on global regulatory guidelines and experience.
Seek opportunities for external regulatory engagement for themselves and/or members of their team.
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.
Position Responsibilities In addition to information in the position summary, the GRS-CMC Associate Director/Director Devices and Combination Products is responsible for the following:
Coordinate and provide oversight/guidance to develop and maintain appropriate procedural documents, white papers and guidelines within GRS-CMC related to devices and combination products Provide oversight to subject matter experts (SMEs) focused on Regulatory-CMC device and combination product guidelines and regulations, including developing and coordinating relationships with Notified Bodies in Europe.
Develop and communicate strategic direction based on global regulatory guidelines and experience.
Work effectively with stakeholders to understand functional interdependencies, assess impact on effective processes, develop mutually agreed-upon optimized processes and drive key cross-functional initiatives and business imperatives Manage and actively support growth and development of direct reports.
Build strong trust-based relationships with stakeholders within the broader Global Regulatory organization, as well as Global Product Development and Supply (GPS).
Degree RequirementsMinimum BA/BS Degree Experience Requirements 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.
Director:
10
years medical device, pharmaceutical or related experience (min BA/BS in Engineering, Pharmacy or related discipline).
10
years CMC regulatory or related experience.
Medical device/software/digital and related combination product development experience Knowledge of CMC regulatory requirements during development and post-approval phases, with emphasis on combination products/medical devices/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 identify trends and changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary Key Competency Requirements Strong oral and written skills Prior management skills preferred Travel RequiredSome travel required #LI-Onsite CA Residents:
Associate Director:
The starting compensation for this job is a range from $164,000-$223,000, plus incentive cash and stock opportunities (based on eligibility).
Director:
The starting compensation for this job is a range from $223,000-$302,000, 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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.
On-site ProtocolPhysical 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.
BMS 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 email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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.
Recommended Skills Assessments Business Priorities Business Processes Clinical Trials Databases Due Diligence Estimated Salary: $20 to $28 per hour based on qualifications.
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