Current jobs related to Associate Director, Global Regulatory Lead - Princeton - Bristol-Myers Squibb Company
-
Director, Global Regulatory Lead
2 months ago
Princeton, United States SUN PHARMA Full timeThe Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...
-
Associate Director, Global Regulatory Sciences
4 months ago
Princeton, United States Bristol Myers Squibb Full timeWorking 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...
-
Director, Global Regulatory Lead
1 month ago
Princeton, United States Sun Pharmaceutical Industries, Inc. Full timeThe Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...
-
Director, Global Regulatory Lead
2 months ago
Princeton, United States Sun Pharmaceutical Industries, Inc. Full timeThe Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...
-
Director, Global Regulatory Lead
1 month ago
PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full timeThe Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...
-
Princeton, New Jersey, United States Bristol Myers Squibb Full timeAbout the RoleThe GRS-CMC organization at Bristol Myers Squibb is seeking a highly skilled and experienced Associate Director, Global Regulatory Sciences to join our team. As a key member of our organization, you will be responsible for providing regulatory expertise related to CMC activities throughout the product lifecycle.Key ResponsibilitiesDevelop and...
-
Princeton, United States Sun Pharmaceutical Industries, Inc. Full timeThe Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), is empowered to provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and (potentially) develop a team of US and/or global regulatory leaders (as...
-
Princeton, United States Sun Pharmaceutical Industries, Inc. Full timeThe Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), is empowered to provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and (potentially) develop a team of US and/or global regulatory leaders (as...
-
PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full timeThe Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), is empowered to provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and (potentially) develop a team of US and/or global regulatory leaders (as...
-
Regulatory Sciences Associate Director
5 days ago
Princeton, New Jersey, United States Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director to join our Global Regulatory Sciences team.About the RoleThe Regulatory Sciences Associate Director will be...
-
Director, Global Regulatory Lead
1 month ago
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeThe Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...
-
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyThe position will provide strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...
-
Regulatory Director
2 weeks ago
Princeton, New Jersey, United States SUN PHARMA Full timeJob SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory...
-
Head of Global Regulatory Operations
4 weeks ago
Princeton, New Jersey, United States SUN PHARMA Full timeThe Director of Regulatory Strategy plays a pivotal role in overseeing the assigned brand initiatives and making all strategic decisions, including outlining the regulatory pathways for development. This position entails engaging with regulatory agencies, collaborating effectively with Contract Research Organizations (CROs), and liaising with various...
-
Regulatory Director
2 weeks ago
Princeton, New Jersey, United States SUN PHARMA Full timeJob SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory...
-
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeThe Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), is empowered to provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and (potentially) develop a team of US and/or global regulatory leaders (as...
-
Regulatory Affairs Director
2 weeks ago
Princeton, New Jersey, United States Genmab AS Full timeAbout the RoleGenmab A/S is seeking a highly skilled Director/Associate Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for developing and executing global regulatory CMC strategies for biological products during early and late-stage development, and lifecycle.Key ResponsibilitiesDevelop and execute...
-
Regulatory Affairs Strategy Director
2 weeks ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs Strategy The position will provide strategic leadership for regulatory affairs and novel drug development programs at Sun Pharmaceutical Industries, Inc. The individual will be responsible for developing and executing the overall regulatory strategy, including registration pathways, interactions with regulatory...
-
Global Safety and Security Director
3 weeks ago
Princeton, New Jersey, United States InsideHigherEd Full timeJob SummaryWe are seeking a highly skilled and experienced Director for the Office of Global Safety and Security to join our team at InsideHigherEd. The successful candidate will be responsible for leading the development and implementation of strategies to ensure the safety and security of our global operations.Key ResponsibilitiesStrategic...
-
Strategic Regulatory Affairs Director
3 weeks ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the...
Associate Director, Global Regulatory Lead
3 months ago
Associate Director, Global Regulatory Lead (Oncology/Hematology) page is loaded
Associate Director, Global Regulatory Lead (Oncology/Hematology)
Apply
locations
Princeton - NJ - US
Madison - Giralda - NJ - US
time type
Full time
posted on
Posted 2 Days Ago
job requisition id
R1582195
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
.
Position Responsibilities
Develop global and/or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities
Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed
Provide strategic direction (and content input) on US Labeling
Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result.
Foster positive relationships with FDA.
Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
Interact routinely and will develop a strong team environment with colleagues throughout GRS
Degree Requirements
Minimum of Bachelors degree required; PhD, MD, PharmD, MS or commensurate
experience preferred
Experience Requirements
Significant experience in regulatory affairs (e.g. 3-5 years)
Key Competency Requirements
Required:
Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA for drug development and approval.
Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
Direct experience in developing strategy and leading teams through interactions with FDA.
Extensive experience in initiating and conducting successful interactions within FDA.
Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals
Other Qualifications:
Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
Communicates opinions, facts and thoughts with clarity, transparency, and honesty
Demonstrates ownership of results within (and beyond) area of
responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Looks for opportunities for continuous improvement.
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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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
adastaffingsupport@bms.com
. 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.
W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
#J-18808-Ljbffr
