Director, Regulatory CMC - Cell Therapy Madison - Giralda - NJ - US R1602987 Posted 19 hours ago
$199.95k - $242.3kBristol-Myers Squibb
- # Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out how well you match with this job**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. 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.The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects. Represent BMS at Health Authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team. Duties/Responsibilities:* Develop and communicate strategic direction based on global regulatory guidelines and experience* Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness* Review submissions from CMC Leads for clarity of both strategic and technical content* Utilize electronic systems for dossier creation, review, and tracking* Manage and actively support growth and development of direct reports* Actively participates in leadership or department meetings* Anticipate and communicate possible regulatory paradigm shifts* Participate in product fact finding meetings and/or R&D forums representing GRS-CMC* Manage relationships with diverse teams* Support the preparation of CMC policies and procedures* Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes Qualifications:**Qualifications** * Minimum BA/BS Degree* Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience Key Competencies:* Knowledge of CMC regulatory requirements for advanced therapies and/or and cell therapy during development and post-approval as applicable* Knowledge of pharmaceutical development, including advanced therapies and/ or, biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products as applicable* Ability to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independently* Ability to interact with CMC technical experts regarding technical issues such as those related to process development and analytical* Understanding of scientific content and complexities and good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration* Experience leading cross-functional teams, demonstrated ability to drive quality decision-making and ability to organize / prioritize tasks* Demonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict management* Direct experience in developing strategy and leading teams through interactions with health authorities, track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components* Strong understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval* Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment; looks for opportunities for continuous improvement* Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies* Communicates opinions, facts and thoughts with clarity, transparency, and honesty and sets clear and high expectations and holds self and others accountable for decisions and results achieved. Demonstrates ownership of results within (and beyond) area of responsibility* Experience as a member of the CMC Team, GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions)* Ability to broadly represent department functions on project team in a matrix organization* Seeks multiple perspectives and listens openly to others’ points of views* Prior management experience preferred* Proficient with electronic systems* This position may require up to 5% of travel*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.*******Compensation Overview:******Madison - Giralda - NJ - US: $199,950 - $242,297 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:* **Health Coverage:** Medical, pharmacy, dental, and vision care.* **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).* **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.**Work-life benefits include:**Paid Time Off* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidaysBased on eligibility\*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.***\*Eligibility Disclosure:** *T*he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.***Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through scienceTM ”, 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 a supportive culture, promoting global participation 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 an 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.**Supporting People with Disabilities**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 View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.**Candidate Rights**BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Protection**We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1602987 : Director, Regulatory CMC - Cell Therapy
- J-18808-Ljbffr Bristol-Myers Squibb
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director, Regulatory CMC - Cell Therapy Madison - Giralda - NJ - US R1602987 Posted 19 hours ago in Madison, NJ vacancy
$199.95k - $242.3k
Working with Us Challenging... ...in cell therapy, this is work... ...us. The GRS-CMC Director is responsible... ...on global regulatory guidelines... ...development and post-approval as... ...Overview: Madison - Giralda - NJ - US: $199,... ...-Exempt, Hourly Employees:... ...with Ripley. R1602987 : Director...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$240.94k - $291.96k
...Working with Us Challenging. Meaningful... ...in cell therapy, this is work that... ...working-with-us . Director, US Regulatory Lead, GRS... ...,940 - $291,964 Madison - Giralda - NJ - US: $215,130 -... ...Exempt, Non-Exempt, Hourly Employees: 160 hours... ...that the job posting is missing information...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workBristol-Myers Squibb
Madison, NJ2 days ago- Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development and lifecycle management projects, ensuring regulatory compliance and strategic direction in alignment with global guidelines...Suggested
$127.28k - $190.92k
...countries, and more than 19,000 employees, we are... ...breakthrough therapies in oncology, cardiovascular... ...position serves as the Regulatory Affairs (RA) CMC project representative... ...assigned developmental and post marketing projects... ...understanding of key US regulatory guidances and...SuggestedDaiichi Sankyo, Inc.
Basking Ridge, NJ1 day ago$225k - $305k
Sr. Director, US Advertising & Promotion, Regulatory Affairs Field of work: Regulatory & Medical Posting Date: 28 May 2026 Role Description Help shape how we bring life‑changing... ...This is a hybrid role, based out of LEO’s Madison, NJ office. Your Responsibilities Provide...SuggestedWork at office- ## Director, BiostatisticsMadison - Giralda - NJ - US**Working with Us**Challenging. Meaningful... ...breakthroughs in cell therapy, this is work that... ...that will support regulatory approval and... ...submissions, and post-submission strategies... ...Overview:******Madison - Giralda - NJ - US...Full timeTemporary work
- Scorpion Therapeutics in Summit, NJ is seeking a QA Leader to oversee compliance with cGMP regulations at the cell therapy manufacturing facility. Responsibilities include managing QA transformation programs and serving as a primary authority for quality assurance during...Flexible hours
$215k - $240k
Application deadline: Location: Madison 07940, New Jersey, United... ...future of dermatology by driving regulatory strategy for LEO Pharma's most... ...you will create and drive the US regulatory strategy for early... ..., based out of LEO's Madison, NJ office. Your Responsibilities...Permanent employmentContract workWork at officeLocal area$178.5k - $257.83k
...Job Title: Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for...Sanofi
Morristown, NJ12 hours ago$106.63k - $129.21k
...breakthroughs in cell therapy, this is work that... ....com/working-with-us .Position Title:Principal... ...at Summit, NJ. This role involves... ...depth knowledge of regulatory guidelines (FDA,... ...Exempt, Non-Exempt, Hourly Employees: 160... ...believe that the job posting is missing information...Hourly payFull timeContract workTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$140k - $165k
...Description Job Title: Manager CMC Regulatory The role involves ensuring... ...to support both pre and post-approval submissions. You will... ...format, style, and architecture of US submissions for assigned... ...position based out of Morristown, NJ. Pay and Benefits The pay...Permanent employmentTemporary workActalent
Morristown, NJ13 days ago$225k - $305k
LEO Pharma is looking for a leader in Madison, New Jersey, to shape the strategy and compliance... ...across the United States. You will manage the US Advertising and Promotion team, ensuring that all activities adhere to regulatory compliance while aligning with business...$184.24k - $276.36k
...Job Title: Director, Regulatory Affairs Advertising and Promotion... ...Requisition ID: 1531 Posting Start Date: 5/21/26... ..., and more than 19,000 employees, we are... ...advancing breakthrough therapies in oncology, cardiovascular... ...~7+ years of US regulatory affairs advertising...Work at officeDaiichi Sankyo, Inc.
Basking Ridge, NJ1 day ago$205k - $240k
...Director, Regulatory Affairs Advertising & Promotion, US The salary range for this position is between $205k and $240k. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to,...For contractorsWork at officeFlexible hoursNight shiftGrünenthal GmbH
Morristown, NJ3 days ago$140k - $165k
...Description Job Description Senior Manager CMC Regulatory A Partner to Actalent is seeking an... ...position based out of Morristown, NJ. Pay and Benefits The pay range for this... ...01(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance...Permanent employmentTemporary workActalent
Morristown, NJ6 days ago- Senior Manager/Director, Regulatory Affairs (Generalist) Are you... ...consultancy headquartered in Madison, New Jersey,... ...biologics, and advanced therapies, giving you the chance... ...activities as a Global or US Regulatory Lead across... ...milestone activities CMC Regulatory Support,...
- ...AbbVie, please visit us at . Follow @... ...The Senior Manager, Regulatory Affairs US Advertising... .... Supports the Director in efforts to influence... ...IL; Florham Park, NJ or Irvine, CA... ...than 2 consecutive hours in an 8 hr day) is... ...at the time of this posting based on the job grade...Full timeLocal area
- ...Morris Plains, NJ Contract Duration: 12-18 months... ...opportunity for an Associate Director in the Morris Plains, NJ area... ...Associate Director in the Regulatory Affairs CMC Department. The successful... ...marketing applications, and post-authorization submissions...Contract workLocal area
Fladger Associates
Morris Plains, NJ3 days ago - ...focused on advancing innovative therapies in non-opioid pain management... ...leadership role will drive regulatory strategy across clinical and nonclinical... ...early development through post-marketing activities Guide... ...Development, Nonclinical, CMC, Commercial, and Executive Leadership...
Kaye/Bassman International
Parsippany, NJ1 day ago - ...AbbVie, please visit us at Follow @abbvie onLinkedIn... ...The Associate Director, Regulatory Affairs US Advertising... ..., IL or Florham Park, NJ headquarters. Significant... ...than 2 consecutive hours in an 8 hr day) is required... ...at the time of this posting based on the job grade...Temporary workWork at office
- Bayer CropScience Limited is seeking a Director of Regulatory Advertising and Promotion to lead strategic regulatory efforts in compliance with U.S. regulations. The ideal candidate will have extensive FDA knowledge, significant experience in promotional submissions, and...
$288.4k
...VP, Head, US Strategy and Execution This role is located in East Hanover, NJ About The Role Reporting into the Chief Strategy, Platforms & Transformation Officer, this role leads the US Strategy & Execution function for the US business and is accountable for shaping...EXACTO Inc
East Hanover, NJ1 day ago$145.6k - $270.4k
Director, Financial Controls & Compliance (FC&C) - US Responsible for planning, executing, and delivering compliance controls and risk advisory services in accordance with Novartis Financial Controls Manual and SOX 404 requirements. Key Responsibilities Lead a multi‑location...Local area$145.6k - $270.4k
Job Description Summary The Director Financial Controls & Compliance (FC&C) US will plan, execute, and ensure delivery of high‑quality compliance, controls testing, and risk advisory that meet Novartis Financial Controls Manual (NFCM) methodology standards, SOX 404 requirements...Local area- Novartis Farmacéutica in East Hanover, NJ seeks a Director of Financial Controls & Compliance to lead a multi‑location team. Responsibilities include ensuring compliance with the SOX 404 standards and managing financial controls. The ideal candidate will have extensive...
- A leading organ technology company in Madison, NJ is seeking a Financial Planning and Analysis Manager to oversee financial planning processes, including forecasting and preparing financial analytics to support senior management. The ideal candidate will possess strong...
$161.25k - $232.92k
...Job Title: Director - US GTM - Consumer/Patient Data Strategy Director Location: Morristown, NJ/Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions, and you can play a vital part in the performance...3 days per weekSanofi Group
Morristown, NJ1 day ago$157.92k - $236.88k
...Job Title: Associate Director, Regulatory (RIM) Business Systems and Operations... ...Requisition ID: 1483 Posting Start Date: 6/8/26 At... ...than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular...Work experience placementDaiichi Sankyo, Inc.
Basking Ridge, NJ3 days ago- ...information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram... ...Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in... ...all phases of development, including post approval and throughout the life cycle of...Temporary workLocal areaWorldwide
AbbVie
Florham Park, NJ9 days ago $33 per hour
...QA Lab Tech Lead NJ Job Category: Quality Full-Time On-site Montville, NJ... ...Provide daily support to all manufacturing cells and other internal customers for Quality related... ...day one. ~ Paid Sick Leave – Up to 40 hours of paid sick time per year, prorated...Full timeImmediate startFlexible hoursRockline
Montville, NJ3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Regulatory CMC - Cell Therapy Madison - Giralda - NJ - US R1602987 Posted 19 hours ago. Be the first to apply!
Related searches
- regulatory Madison, NJ
- regulatory law Madison, NJ
- therapy technician Madison, NJ
- therapy Madison, NJ
- massage therapy instructor Madison, NJ
- therapy physical therapist Madison, NJ
- therapy manager Madison, NJ
- massage therapy part time Madison, NJ
- respiratory therapy manager Madison, NJ
- import compliance manager