Associate Director, Global Regulatory Strategy, Hematology
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.
Responsibilities Leadership responsibility for global regulatory strategy within the Hematology portfolio.
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
Contribute in developing target labeling.
Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
In collaboration with the Global Regulatory Subteam, develop global submission plans and HA interaction plans.
Provide input into the development of protocol synopses and protocols.
Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
Qualifications Solid scientific background (PhD, MD, Pharm.
D.
, BS or MS in regulatory science) with 4
years in the pharmaceutical industry.
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance.
Experience as a member of Global Regulatory Subteam, project working groups, or comparable experience.
Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
Experience utilizing leadership techniques to drive a team through the stages of team development.
Experience coordinating communications within teams and across functions.
Experience applying project management techniques within teams.
Experience in effectively managing meetings.
Demonstrated ability to breakdown complex, scientific content into logical components.
Demonstrated ability to coordinate global activities.
Demonstrated ability to facilitate issue resolution and conflict management.
Demonstrated ability to drive quality decision-making.
Demonstrated ability to organize/prioritize tasks.
Demonstrated ability to negotiate with and influence others.
Understanding of strategic and tactical role for the antithrombotic drug development process.
Understanding of general global regulatory requirements for drugs in development.
Understanding of R&D process and specific regulatory responsibilities/deliverables for the company Decision Points 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 the resources to pursue their goals, both at work and in their personal lives.
The starting compensation for this job is a range from $141,000 - $210,000, 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 where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following:
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.
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 Clinical Trials Clinical Works Communication Conflict Management Coordinating Decision Making 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.
Responsibilities Leadership responsibility for global regulatory strategy within the Hematology portfolio.
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
Contribute in developing target labeling.
Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
In collaboration with the Global Regulatory Subteam, develop global submission plans and HA interaction plans.
Provide input into the development of protocol synopses and protocols.
Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
Qualifications Solid scientific background (PhD, MD, Pharm.
D.
, BS or MS in regulatory science) with 4
years in the pharmaceutical industry.
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance.
Experience as a member of Global Regulatory Subteam, project working groups, or comparable experience.
Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
Experience utilizing leadership techniques to drive a team through the stages of team development.
Experience coordinating communications within teams and across functions.
Experience applying project management techniques within teams.
Experience in effectively managing meetings.
Demonstrated ability to breakdown complex, scientific content into logical components.
Demonstrated ability to coordinate global activities.
Demonstrated ability to facilitate issue resolution and conflict management.
Demonstrated ability to drive quality decision-making.
Demonstrated ability to organize/prioritize tasks.
Demonstrated ability to negotiate with and influence others.
Understanding of strategic and tactical role for the antithrombotic drug development process.
Understanding of general global regulatory requirements for drugs in development.
Understanding of R&D process and specific regulatory responsibilities/deliverables for the company Decision Points 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 the resources to pursue their goals, both at work and in their personal lives.
The starting compensation for this job is a range from $141,000 - $210,000, 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 where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following:
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.
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 Clinical Trials Clinical Works Communication Conflict Management Coordinating Decision Making Estimated Salary: $20 to $28 per hour based on qualifications.
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