Senior Director, Global Regulatory Lead Neuroscience
$258.68k - $313.46kBristol Myers Squibb
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](#).
Sr Director, Global Regulatory Strategy, Neuroscience
- Will be a key member of the GRSP Extended Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area.
- Acts as regulatory representative on various company-wide projects and initiatives.
- Support due diligence and business development assessments.
- Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products:
- Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products. Review/provide counsel on product development plans.
- Assemble the global regulatory plans for identified projects/products.
- Influences and imparts broad expertise regarding US and international regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.
- Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects.
- Serve as the primary interface with health authorities on assigned projects.
- Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them.
- Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources. Works with regional international staff for diverse health authority submissions.
Skills / Requirements
- Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in neurology, neuromuscular diseases or neuropsychiatry drug development strongly preferred.
- 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired.
- Thorough knowledge of the drug research, development, and commercialization process.
- Demonstrated specific expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve critical/complex business problems.
- 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.
- 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 holidays
$258.68k - $313.46k
...careers of those who do it. Sr Director, Global Regulatory Strategy, Neuroscience Will be a key member of the GRSP... ...staff as Global Regulatory Lead and US Regional Regulatory Lead on... ...Candidate Home Account. R1603594 : Senior Director, Global Regulatory Lead...SeniorHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours$230.44k - $279.23k
...the careers of those who do it. The Senior Director, Compliance Policy & Education is a... ...and operating model for these programs globally and leads a team responsible for policy... ...enterprise risks, business priorities, and regulatory expectations. Serve as the primary...SeniorHourly payFull timeSummer workLive inLocal areaRemote workWorldwideFlexible hours- Johnson & Johnson is seeking an Advanced Demand Analytics Lead to drive global demand analytics for the Innovative Medicine Supply Chain. The role emphasizes ownership of dashboards, cross-functional collaboration, and scalable analytics across regions with up to 10% travel...Senior
$97.5k - $126.5k
Company DescriptionRamboll is a global architecture, engineering, and... .... Ramboll is hiring for a Lead Consultant to join the Mergers... ...to clients across a variety of regulatory program areas including hazardous... ...level: Mid-Senior LevelIndustry: Environmental ServicesSeniorFull timeWork at officeLocal areaFlexible hours$97.5k - $126.5k
Company DescriptionRamboll is a global architecture, engineering, and consultancy company. As a foundation-owned people company, founded... .... Join our Environment & Health Department as our new Senior Lead Consultant in Acoustics and work with us to close the gap to a...SeniorFull timeWork at officeLocal areaRemote work$220k - $300k
...SystImmune is a leading and well-funded clinical-stage biopharmaceutical... ...company's success. The Regulatory Affairs (Clinical/Nonclinical... ...Department in all aspects of global regulatory affairs related to... ...role could range across Director/Sr. Director/Exec Director based...Senior$242k - $315k
...preventable, curable and no longer the leading cause of death in the world.... ...’s growth toward becoming a global, multi-product commercial-... ...readiness and management, regulatory surveillance, and other... ...for mana gement revi ew and senior leadership on compliance status...SeniorFor contractorsRemote work$137k - $167.5k
POSITION SUMMARYThe Senior Regulatory Compliance Manager is responsible for providing independent quality assurance assessment of global regulatory compliance activities supporting clinical... ...of the Development Quality Assurance Leads ensuring investigational products,...SeniorLocal areaFlexible hours- ...are dedicated to helping people lead longer and healthier lives. We... ...We are seeking Senior Manager / Lead Associate Strategy... ...materials with the Head of SRx and global Corporate Development. Commercial... ..., and the U.S. pharmaceutical regulatory, intellectual property, and...SeniorPermanent employmentContract workVisa sponsorship
$222k - $303k
...does every person who joins in. As a global biopharmaceutical company dedicated to... ...you?About the Role:We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us... ...Director will serve as the regulatory lead at the CMC sub team level and as an ad...SeniorFull timeLocal areaRemote workFlexible hours$137k - $228k
Global Supply Chain Lead, Pharma SolutionsBuild and Personally Deliver the Supply Chain Backbone of a Growing Global Pharma BusinessPharma Solutions is a growing business within Croda, serving pharmaceutical, biotechnology, and veterinary-health customers through innovative...Contract work$210.9k - $379.2k
...strategic partners worldwide, contributing to global health initiatives.Moderna's commitment... ....Moderna is seeking a Global Medical Lead to lead medical affairs strategy across our... ...The role will interface extensively with regulatory, clinical, commercial, and external...Permanent employmentFull timeWork at officeWork from homeWorldwide$196.7k - $353.4k
...Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be... ...as unprecedented new drug modality globally. The Sr. Director will be a strategic... ...Affairs the Project Team and senior management, as relevant.May be responsible...SeniorPermanent employmentFull timeWork at officeWork from home$105.79k - $141.05k
...connectivity, join us today. The Role The Sr. Lead, GTM Growth Platforms is a critical role... ...GTM team, reporting directly to the Sr. Director, Integrated Demand & GTM. This individual... ...personal data. To review Lumen’s Global Employment Applicant and Talent Community...SeniorFull timeTemporary workRemote work$290k - $350k
...Executive Director, Global Medical Affairs Lead - Oncology Reports to: SVP, Head of Clinical Development and Medical Affairs Location: Remote... ...activities with the company's strategic objectives and regulatory requirements. The ideal candidate will have a strong background...Remote work$157.6k - $205.43k
...Description Introduction Axtria is a leading global provider of cloud software and data... ...Description Axtria is looking for a Senior Omnichannel Orchestration Lead to join... ...orchestration design complies with the regulatory, legal, and privacy requirements governing...SeniorHourly pay$96.68k - $120.85k
Company DescriptionRamboll is a global architecture, engineering, and... ..., the selected candidate will lead and support multidisciplinary... ...technical specialists.As a senior member of the team, you will apply... ...deliverables, and support regulatory and client communications. You...SeniorFull timeWork at office- ...Kardigan is seeking a Vice President, Global Program Head to lead a cardiovascular development program from late-stage research through launch... ...to the Chief Development Officer, partner with Clinical, Regulatory, Safety, Manufacturing, Medical, and Commercial leaders,...
$164.02k - $198.76k
...GRS-CMC organization provides regulatory expertise related to CMC... ...of the organization develop global regulatory CMC strategies and... ...products. The GRS-CMC Associate Director is responsible for content development... ...(including participating/leading HA meetings); and/or post-...Hourly payFull timeSummer workLive inLocal areaRemote workFlexible hoursShift work- ...Novo Nordisk A/S seeks a Global Project Leader in Plainsboro, NJ to... ...with enterprise impact. You will lead cross-functional teams across discovery, development, and regulatory stages, interfacing with... ...bodies. The role requires senior leadership experience, strategic...Senior
$105.79k - $141.05k
...future of AI‑ready connectivity, join us today. The Role The Senior Lead Marketing Manager will shape scalable, integrated marketing... ...to or deletion of their personal data. To review Lumen’s Global Employment Applicant and Talent Community Privacy Notice, please...SeniorFull timeTemporary workWork from home- ...Executive Director, Global Medical Affairs Lead, Oncology About the Company Innovative biopharmaceutical company Industry Pharmaceuticals... ...in line with the company's strategic objectives and regulatory requirements. This pivotal role demands a leader with a...Remote work
- ...Novo Nordisk’s Plainsboro-based team seeks a Global Project Leader (GPL) to oversee complex product projects with enterprise impact.... ...functions. The role demands a broad T-profile across scientific, regulatory, commercial, manufacturing, and operations areas, with a track...Senior
- ...Johnson & Johnson is seeking a Senior Immunology & Neuroscience Supply Chain Leader to act as the strategic partner across Commercial, Deliver, and Planning teams. You will connect market, customer, patient, and commercial insights with Supply Chain strategy, shaping...Senior
- Croda is seeking a Global Supply Chain Lead for Pharma Solutions to design and deliver a world-class planning and execution backbone. The role will personally drive planning governance, data standards, and continuous improvement across a global matrix, balancing strategic...
$103.71k - $138.28k
...connectivity, join us today. The Role We are seeking a Senior Product Marketing Manager to lead go-to-market strategy for Lumen's secure access... ...deletion of their personal data. To review Lumen’s Global Employment Applicant and Talent Community Privacy Notice...SeniorFull timeTemporary workLocal areaRemote work- ...Church & Dwight Co., Inc. seeks a Sr. Director, Supply Chain Business Partner for Waterpik... ...market for new products. The role oversees global supply teams in USA/China with 30–50%... ...Care. Based in Ewing, NJ or China, this senior leader will manage capacity, CM networks,...Senior
- A leading healthcare organization is seeking a Senior Patient Safety and GxP Document Oversight Manager in Plainsboro Township, NJ. This role involves overseeing... ...interpersonal and analytical skills to support regulatory requirements and continuous improvement initiatives...Senior
$111k - $135.5k
...ResponsibilitySubject matter expert (SME) understanding of sterile manufacturing and packaging.Leads the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.QA SME for manufacturing (Sterile & OSD), environmental monitoring,...Flexible hours- ...what’s possible and making headway to help improve outcomes.The Global Trade & Compliance Optimization Manager is an individual contributor... ...focus on transatlantic (US-EU) and EMEA trade flows.This role leads global HS classification strategy, origin analysis, and tariff...Full time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Global Regulatory Lead Neuroscience. Be the first to apply!
- regulatory cmc manager Princeton, NJ
- manager regulatory affairs Princeton, NJ
- regulatory & compliance manager Princeton, NJ
- senior regulatory manager Princeton, NJ
- director regulatory affairs cmc Princeton, NJ
- regulatory affairs manager pharmaceutical Princeton, NJ
- senior director regulatory affairs Princeton, NJ
- compliance director Princeton, NJ
- compliance manager Princeton, NJ
- director global regulatory affairs Princeton, NJ





