Director, CMC Regulatory Strategy for Cell Therapy

Bristol-Myers Squibb Company

Bristol Myers Squibb seeks a GRS-CMC Director to oversee multiple development and lifecycle management projects, guiding regulatory strategy in CMC to support global filings. You will lead cross-functional teams, mentor staff, and represent BMS in Health Authority meetings while ensuring timely, compliant submissions. This role is based in Princeton, NJ, offering a mission-driven culture with growth opportunities and comprehensive benefits. #J-18808-Ljbffr

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Director, CMC Regulatory Strategy for Cell Therapy in Princeton, NJ vacancy

Director, Regulatory CMC - Cell Therapy
...those who do it. The GRS-CMC Director is responsible for overseeing... ...direction based on global regulatory guidelines and experience.... ...requirements for advanced therapies and/or and cell therapy during development... ...global regulatory strategies in coordination with clinical...
Suggested
Shift work
Bristol-Myers Squibb Company
Princeton, NJ
3 days ago
Senior Director, Global CMC Regulatory Strategy
...Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head of CMC Regulatory and collaborates with cross-functional teams across development and manufacturing in...
Suggested
Kardigan, Inc.
Princeton, NJ
4 days ago
Senior Director, Regulatory Affairs CMC - Gene Therapy
$222k - $303k
...in. Are you?About the Role:We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what’s possible for patients with... ..., and implement a well-crafted global regulatory CMC strategy plan to facilitate efficient and competitive product...
Suggested
Full time
Local area
Remote work
Flexible hours
Insmed
Trenton, NJ
5 days ago
Executive Director, Neuroscience Global Commercial Strategy Princeton - NJ - US R1604681 Posted[...]
$239.08k - $289.71k
## Executive Director, Neuroscience Global Commercial StrategyPrinceton... ...latest breakthroughs in cell therapy, this is work that... ...Neuroscience Global Commercial Strategy will serve as a senior commercial... ...with Development, Medical, Regulatory, CMC, Commercial, and Strategy &...
Suggested
Hourly pay
Full time
Temporary work
Part time
For contractors
Summer work
Live in
Work at office
Local area
Remote work
Worldwide
Flexible hours
Shift work
Bristol-Myers Squibb
Princeton, NJ
3 days ago
Director, Regulatory CMC
$193.63k - $254.14k
...are advancing the next generation of cell therapy through a portfolio of innovative... ...myeloma. Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs... ..., and execute global CMC regulatory strategies across commercial products and...
Suggested
Permanent employment
Full time
Temporary work
For contractors
Local area
Worldwide
Flexible hours
Legend Biotech USA, Inc.
Somerset, NJ
a month ago
Sr. Director, Regulatory Strategy, Infectious Disease
$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...and approves technical data in partnership with RA CMC and verifies accuracy of clinical data and execution of clinical...
Permanent employment
Full time
Work at office
Work from home
Moderna Therapeutics
Princeton, NJ
4 days ago
Sr. Director, Regulatory Strategy, Infectious Disease
$196.7k - $353.4k
...The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...and approves technical data in partnership with RA CMC and verifies accuracy of clinical data and execution of clinical...
Permanent employment
Full time
Work at office
Work from home
Moderna
Princeton, NJ
4 days ago
Director Regulatory Affairs Strategy
...Description Job Description Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with...
Lynkx Staffing LLC
Princeton, NJ
more than 2 months ago
Director, Regulatory Affairs CMC
$212.5k - $250k
...our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC.... ...expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post...
For contractors
Local area
Taiho Oncology, Inc.
Princeton, NJ
2 days ago
Director, Regulatory Affairs CMC
$189.7k - $237.1k
Position Summary Director, Regulatory CMC. Role can be based in San Diego, CA; San Francisco, CA; or Princeton, NJ. Hybrid model: work in office... ..., and other functions to develop/implement CMC regulatory strategy. Prepare high-quality CMC sections of INDs, CTAs, NDAs, MAAs...
Work at office
Worldwide
3 days per week
Acadia Pharmaceuticals
Princeton, NJ
5 days ago
Director Regulatory Affairs (CMC)
...Job Description Our Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs...
Work at office
Lynkx Staffing LLC
Princeton, NJ
18 days ago
Market Access Channel Strategy Trade Director
$187k - $327k
...Access and Public Affairs professionals ensure that the latest therapies and products reach the people who need them most, by... ...realize your potential?The PositionThe Market Access Trade Strategy Director is part of a team responsible for developing channel strategies...
Temporary work
Local area
Home office
Flexible hours
Night shift
Novo Nordisk Pharma
Plainsboro, NJ
4 days ago
Clinical Supply Planning Manager
$139k - $142k
...including:Non-small Cell Lung Cancer (NSCLC)... ...an investigational therapy not presently approved by any regulatory authority other... ...support to the Associate Director, Clinical Supply... ...accountability for study-level strategy, decisions, and... ...analyses for the CMC/Supply Chain team....
Summit Therapeutics
Princeton, NJ
3 days ago
Senior Manager, Omnichannel Strategy-Oncology
$135.2k - $202.8k
...Senior Manager, Omnichannel Strategy will serve as the omnichannel... ...critical role will report to the Director of Omnichannel Strategy and... ..., partnering with Regulatory, Legal, and Medical through promotional... ...pipeline including bispecific T-cell engagers, antibody-drug...
Full time
Fixed term contract
Work at office
Genmab
Princeton, NJ
6 days ago
Head of Business Continuity Planning
$195k - $240k
...next generation of antibody, cell, and gene therapies, with particular emphasis... ...alternatives.Summary of Job:The Director of Strategic Initiatives... ...:Collaborate closely with strategy team and/or senior... ...Insightful understanding of regulatory and legal requirements for...
Summer work
Local area
Worldwide
Flexible hours
Kyowa Kirin
Princeton, NJ
6 days ago
AI Governance & Assurance Strategy Manager
$161.93k - $269.88k
...AI service delivery capabilities. The ideal candidate brings strategy and operations expertise, as well as AI expertise and demonstrable... ...& AssuranceDirectly align with enabling areas (e.g. PPN, Regulatory, Marketing & Comms, Sales Excellence) to ensure the AI Assurance...
Full time
Local area
Visa sponsorship
Deloitte
Princeton, NJ
7 days ago
Director, Digital Channel & Content Strategy, Communications & Corporate Affairs
$174.72k - $262.08k
...would love to have you join us! Director, Digital Channel & Content Strategy Communications & Corporate Affairs... ...~ Familiarity with compliance and regulatory considerations in healthcare or... ...proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates...
Full time
Fixed term contract
Work at office
Worldwide
Genmab A/S
Princeton, NJ
3 days ago
Sr. Director/Executive Director, Regulatory Affairs - Oncology Biotech (Princeton)
$200k - $300k
...contributions to the company's success. The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development... ...modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). The primary area of focus is...
SystImmune Inc.
Princeton, NJ
5 days ago
Senior Manager, Quality Systems & Compliance
...About Made Scientific Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO)... ...internal audit activities, ensuring full compliance with GMP and regulatory requirements. The ideal candidate has deep expertise in...
Contract work
MADE Scientific Inc
Princeton, NJ
3 days ago
Associate Director, Regulatory Data Management & Intelligence
$142.5k - $256.5k
...the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate... ...advancing Moderna’s regulatory data strategy, governance framework, and digital data... ...Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data,...
Permanent employment
Full time
For contractors
Work at office
Work from home
Moderna Therapeutics
Princeton, NJ
6 days ago
Associate Director, Regulatory Affairs - Biosimilars (US)
$145.6k - $279.4k
...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for biosimilar development and marketed... ...in partnership with Clinical, Nonclinical, CMC, Analytical Development, Quality, Pharmacovigilance...
Work at office
Visa sponsorship
Work visa
Relocation package
U023 (FCRS = US023) Sandoz Inc
Princeton, NJ
2 days ago
Head of Business Analysis and Planning
Director, Wealth Planning & Strategy Location: Princeton, NJ or Bethesda, MD area Level: Director or Senior Director, based on experience Employment type: Full-time, in-person (Hybrid) About OneWell OneWell is an SEC-registered investment adviser serving ultra...
Full time
Work at office
OneWell
Princeton, NJ
3 days ago
Senior Manager, Pricing Strategy and Contract Analytics - Market Access, Princeton, NJ - Hybrid
$127k - $155k
...analyses that support pricing, contracting, and market access strategies across Sun Pharma's U.S. innovative medicine portfolio. This role... ...that support strategic business decisions.Reporting to the Director, Business Pricing Strategy & Contract Analytics, this position...
Contract work
Flexible hours
Sun Pharmaceutical Industries
Princeton, NJ
8 days ago
Associate Director, Marketing, Professional Promotion, HCP Strategy (Head & Neck Oncology)
$176.4k - $264.6k
...you join us! The Role The Associate Director (Head & Neck Oncology) Marketing... ...will shape, implement, and execute brand strategies for Genmab’s Head and Neck Cancer team.... ...proprietary pipeline including bispecific T‑cell engagers, antibody‑drug conjugates, next...
Fixed term contract
Work at office
Genmab A/S
Princeton, NJ
3 days ago
Business Operations & Integration (BO&I) US Operate Business Strategy Manager
$118.7k - $243.7k
Position Summary The US Operate Strategy & Execution team is a cross-business strategy function that helps shape and execute the growth agenda for BO&I US Operate, specifically supporting the build of new capabilities that further our LTP aspirations. We work alongside...
Work at office
Local area
Deloitte
Princeton, NJ
5 days ago
Director, Product Management, Content Strategy & AI Readiness
$166.9k - $298.3k
..., and apply that knowledge, our content strategy must evolve so content remains authoritative... ...responsible AI-powered experiences. As Director, Product Management, Content Strategy &... ...Experience with healthcare, clinical, regulatory, or professional-information content. Experience...
Full time
Work at office
Wolters Kluwer
Princeton, NJ
8 days ago
Global Medical Affairs Planning & Effectiveness, Content Platform Lead -Job 2033
$190k - $210k
...and potentially best-in-class therapies to address unmet medical... ...governance framework, and technology strategy for Medical Affairs content... ...across Medical Affairs, Regulatory Affairs, Market Access,... ...Partner or Human Resources Director) is not allowed. If this occurs...
Full time
Temporary work
Local area
Flexible hours
ascendis pharma
Princeton, NJ
6 days ago
Global Labeling Strategy Director
...Ascendis Pharma is seeking a strategic Director, Head of Global Labeling to lead the worldwide... ...bodies, shape development labeling strategies, and collaborate across Legal, Clinical... ...Affairs, and Market Access to drive regulatory excellence. The role requires deep global...
Worldwide
Ascendis Pharma A/S
Princeton, NJ
2 days ago
DMPK Director - Strategy, Studies & Submissions
...with a PhD and at least 12 years of experience in drug discovery. Responsibilities include overseeing DMPK strategies, interpreting data, and drafting regulatory documents. The role allows for a hybrid working environment with competitive salary and full US benefits. This...
QuantX Biosciences
Princeton, NJ
2 days ago
Director, Creative Strategy & Brand
$187.34k - $227.01k
...combines scientific research with a purpose-driven culture focused on transforming patients' lives. The role The Director of Creative Strategy and Brand Stewardship sits within the Corporate Communications team and the broader Corporate Affairs organisation. The...
Hourly pay
Full time
Summer work
Flexible hours
Hard Problems
Princeton, NJ
5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, CMC Regulatory Strategy for Cell Therapy. Be the first to apply!