Global Regulatory Operations Leader, AI-Driven Submissions
Jobr
jobr.pro is seeking a Senior Director of Regulatory Operations to lead strategic and operational efforts globally. This key role involves ensuring compliance and driving innovation in regulatory submissions, while collaborating with cross-functional teams to implement advanced systems and technologies. Ideal candidates will have over 12 years in regulatory affairs, including strong leadership in electronic submissions. This position offers a competitive salary and benefits, with a hybrid work model based in San Diego, CA. #J-18808-Ljbffr
- ...Pharmaceuticals Inc. is seeking a Senior Director, Regulatory Operations based in Princeton, NJ. This role requires providing strategic leadership for global regulatory operations and ensuring timely, high-quality submissions. The ideal candidate will have over 12 years of...Regulatory
- ## Strategy and Operations, Associate DirectorPrinceton... ...Data Science driven pharmaceutical... ...strategic agenda. This leader will drive... ...company policies, regulatory requirements, and... ...for expertise in AI/Automation* **Strategic... ...culture, promoting global participation in clinical...RegulatoryFull timeTemporary work
$160k - $175k
...A global biopharmaceutical company in Princeton, New Jersey is seeking a Regulatory Project Manager to lead key regulatory submissions. The ideal candidate will have at least 8 years of experience in regulatory affairs, a degree in life science, and strong project management...Regulatory$160k - $175k
...A leading global biopharmaceutical company located in Princeton, New Jersey, is seeking a Regulatory Project Manager to provide project management leadership for key regulatory submissions. The role requires a minimum of 8 years in Regulatory Affairs with strong organizational...Regulatory- ...standards of care. The Global Senior Manager, IT... ...technology risk, regulatory developments, and... ...(e.g., cloud, AI, cybersecurity).... ...data privacy, and operational resilience. o Lead... ...Finance, business leaders, and external... ...Unsolicited Agency Submission Integra LifeSciences...RegulatoryFull timeTemporary workWork at office
$299.6k
...The Vice President, Global Regulatory Affairs Strategy is a... ...regulatory compliance and operational efficiency on a... ..., and accountability driven by the Head of RA. Support... ...teams, direct submissions, and ensure regulatory... ...Inspirational people leader with a strong track record...RegulatoryWork at office$81.65k - $112.7k
...The Sr. Project Manager, Global Supplier Quality Systems is... ...Manager partners with Quality, Regulatory, Operations, and IT to ensure effective... ...metrics, enabling data-driven decisions and continuous improvement... ...com. Unsolicited Agency Submission Integra LifeSciences...RegulatoryTemporary work$166.75k - $228.85k
...The Director of Commercial Sales Operations Revenue Capture will lead a global team of managers and analysts responsible... ...the Sales organization with data-driven tools to guide pricing and... ...integralife.com. Unsolicited Agency Submission Integra LifeSciences does not...Contract workTemporary workWork at office- ...Planet Pharma Group, based in Lawrenceville, New Jersey, is seeking a Regulatory Operations Lead to oversee compliance for the global movement of preclinical materials. The role demands extensive knowledge of Partner Government Agency requirements and a collaborative spirit...Regulatory
- ...power Otsuka Pharmaceutical's global business operations. It focuses on creating... ...operational excellence, and data-driven decision-making. As a key... ..., GxP, data-privacy, and regulatory requirements (e.g., GDPR,... ...services, DevOps tooling, AI frameworks, and automation...Regulatory
$150.03k - $224.25k
...power Otsuka Pharmaceutical's global business operations. It focuses on creating... ...operational excellence, and data‑driven decision‑making. As a key... ..., GxP, data‑privacy and regulatory requirements (GDPR, HIPAA).... ...services, DevOps tooling, AI frameworks and automation platforms...RegulatoryTemporary workFlexible hoursShift work- Merck & Co. in Plainsboro Township, NJ, seeks a Regulatory Ops Labeling Manager to oversee pharmaceutical labeling processes. The role requires overseeing final printed labeling for life cycle management, collaborating with cross-functional teams, and ensuring compliance...Regulatory
$180k - $230k
...highly skilled and motivated Global Director, Clinical Project... ...completion, ensuring compliance with regulatory requirements, managing study... ...aspects of clinical trial operations, including site selection,... ...Ensure the preparation and submission of regulatory documents are...RegulatoryWork at officeLocal areaNight shift- ...enabler of scientific and operational excellence. We are seeking an exceptional executive leader to join our Global Operations Leadership Team... ...across pharma, biotech, and regulatory bodies Ensure world‑class GXP... ...in a modern, science‑driven environment. FR : Dans le cadre...Regulatory
$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of... ...investigational and marketed prescription drug submissions and manages lifecycle activities for... ...labeling, medical writing, regulatory operations, etc.) to develop global regulatory...RegulatoryTemporary workWork at officeLocal areaFlexible hours$258k - $336k
...leading team that is driven to improve the lives... ...: Development Operations & Biometrics... ...to the clinical and regulatory strategy and submissions. Reporting to the VP... ...CFR Part 11, GCP) and global data standards & regulatory... ...capabilities through AI and Automation solutions...Regulatory$180k - $230k
...highly skilled and motivated Global Director, Clinical Project... ...involves ensuring compliance with regulatory requirements, managing study... ...aspects of clinical trial operations, including site selection,... ...Ensure the preparation and submission of regulatory documents are...RegulatoryWork at officeLocal areaNight shift$297.59k - $360.6k
...hiring an Executive Director, Global Program Leader, Pumitamig. This individual... ...debate and rapid, data-driven decision making; and (iii)... ...therapeutic advances, and evolving regulatory, patient advocacy and... ...alignment of program strategy and operational plans with functional area...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$120.3k - $222.6k
...Department The Finance & Operations department brings... ...build a career in a global business environment.... ...guidelines, legal and regulatory policies, while minimizing... ...documents and timely submission of contracts to... ...100 years, we've been driven by a single purpose: to...RegulatoryContract workLocal areaFlexible hoursNight shift- ...Hengrui Medicine (600276 SHA), a global pharmaceutical company with... ...About the Role Regulatory Publishing Specialist supports... ...formatting, compilation, and submission of regulatory documents to... ...procedures, while providing operational support to the Regulatory Affairs...RegulatoryWork at office
$183.34k - $274.16k
...Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling... ...deliver value-added results.* Proven matrix leader with excellent problem-solving innovative... ...candidate should be action oriented, client-driven, ability to manage workloads and set...RegulatoryTemporary workLocal areaWorldwideFlexible hours- ...leading pharmaceutical organization is seeking an experienced Project Manager for Regulatory & Medical Affairs in Lawrence Township, NJ. This role involves overseeing the preparation and submission of regulatory dossiers, ensuring compliance with regulations, and managing a...Regulatory
- ...A leading pharmaceutical company in Princeton, NJ is seeking a Regulatory Affairs expert to drive the labeling strategy and ensure global compliance. The role involves leading cross-functional teams, mentoring peers, and executing strategic labeling initiatives. Qualified...RegulatoryWorldwide
- ...Merck & Co. is seeking a Head of Regulatory Affairs in Plainsboro Township, NJ. This role involves defining and leading regulatory strategy for product submissions and approvals, and engaging with the U.S. FDA to ensure compliance. Candidates must have a doctorate or...Regulatory
- ...Astrix Inc. is seeking a Senior Regulatory Affairs Specialist in Princeton, NJ. In this part-time role, you'll play a key role in the development... ...years of experience in Regulatory Affairs, strong knowledge of global regulations, and excellent communication skills. This position...RegulatoryPart time
- ...Genmab A/S is seeking a Vice President, Global Regulatory Affairs Strategy in Princeton, NJ. This key leadership role focuses on managing regulatory strategy for a portfolio of assets throughout development phases. Responsibilities include leading regulatory strategy programs...Regulatory
- ...Systimmune, located in Princeton, NJ, is seeking a Global Director for Clinical Project Management to oversee global clinical trials... ...from start to finish. This role involves ensuring compliance with regulatory standards, managing study timelines and budgets, and...Regulatory
- ...Legend Biotech USA is seeking a Senior Manager, Congress Strategy & Operations to oversee the planning and execution of global oncology and hematology congresses. This role requires a minimum of 5 years’ experience in congress planning within the pharmaceutical industry...
$204k - $244k
...Scorpion Therapeutics is seeking a Director, Regulatory Affairs – CMC in Cranbury Township, New... ...role involves developing and executing global Regulatory-CMC strategies for gene... ..., leading the preparation and review of submission documents, and interacting with health authorities...Regulatory$172k - $234k
...industry-leading team that is driven to improve the lives of... ...SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs,... ...analyses, and reports. Develop global tools, such as macros or... ...(SDTM, ADaM) and regulatory submission requirements. Good knowledge...RegulatoryFor contractors
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