Global Regulatory Submissions Lead
Artech Information Systems LLC
A 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 team. Ideal candidates should have substantial pharmaceutical industry experience with expertise in regulatory processes and knowledge of electronic submission requirements. Competitive salary and benefits offered, including opportunities for professional development. #J-18808-Ljbffr
$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$249.97k - $388.13k
...Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global... ...and other evidence generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated value of our...RegulatoryTemporary workLocal areaFlexible hours- ...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...Regulatory
$299.6k
...The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory... ...a global scale. Key Responsibilities Lead delivery of regulatory strategy... ...relationships between regulatory teams, direct submissions, and ensure regulatory compliance....RegulatoryWork at office$238.89k - $289.48k
...with-us .Position SummaryThe Director, Global Trial Lead (GTL) is accountable for the strategic... ...alignment with business objectives, regulatory standards, and quality benchmarks. As... ...regulatory requirements. Ensures readiness for submissions and compliance with global standards....RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...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
- ...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... ...throughout development phases. Responsibilities include leading regulatory strategy programs, engaging with health...Regulatory
$341.36k - $413.65k
...working-with-us. Position Summary: The Global Program Lead (GPL) will serve as the “point of... ...functional GPT members Participates in regulatory filings (NDA, BLA filings), engaging with... ...and navigating competing demands Prior submission experience is preferred Prior cell...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$249.97k - $388.13k
...the safety profile of Otsuka products Leads the development and execution of medical... ...Provides strategic leadership of the Global Medical review function and collaborates... ...for medical review matters to engage with regulatory agencies on product safety issues. Key...RegulatoryContract workTemporary workLocal areaFlexible hours$254.53k - $308.43k
...scientifically deployable for the MEG, MAP & RWE and Global Medical teams. Specifically, the role... .... Responsibilities Build & Lead the RWD Innovation Center... ...propensity methods, eligibility alignment, and regulatory considerations Hybrid designs: integrating...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$286.31k - $346.95k
...: careers.bms.com/working-with-us . Position Summary Global Program Leads at BMS are strategic-thinking, problem-solving, and action... ...trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$91k - $147.2k
...& Johnson Family of Companies is recruiting for an MTST Global Finance Reporting Lead - Endomech and Energy to be located in either Cincinnati... ...numbers, your applications will be considered as a single submission. At Johnson & Johnson,we believe health is everything....Full timeTemporary workLocal areaRemote workWorldwide- ...Description Job Description Title : Lead Associate- OTC Department : Regulatory Affairs Reports To : Team Lead... ..., review and approval of submission artworks and private label), Bill... ...submissions to the FDA Coordinate with global RA team to facilitate post...Regulatory
$204k - $244k
...Therapeutics is seeking a Director, Regulatory Affairs – CMC in Cranbury Township, New... ...involves developing and executing global Regulatory-CMC strategies for gene therapy products, leading the preparation and review of submission documents, and interacting with health...Regulatory- ...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
- ...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
$109.25k - $149.5k
...standards of care. SUMMARY The Lead Auditor, Quality Compliance... ...ISO, GMP, GDP, GCP, and GLP, global policies/procedures and... ...policies and procedures and the regulatory and legislator requirements... ....com. Unsolicited Agency Submission Integra LifeSciences does...RegulatoryTemporary workWork experience placement$109.25k - $149.5k
...standards of care. SUMMARY The Lead Auditor, Quality Compliance... ...ISO, GMP, GDP, GCP, and GLP, global policies/procedures and... ...policies and procedures and the regulatory and legislator requirements... ...integralife.com. Unsolicited Agency Submission Integra LifeSciences does...RegulatoryTemporary workWork experience placement- ...searching for a Principal Portfolio Lead, Statistical Programming -... ...related aspects of regulatory agency inspections and J&J internal... .... Provides input to submission strategy to regulatory agencies... ...limited to: Statistics, Clinical, Global Medical Safety, Project...RegulatoryFull timeTemporary workWork at officeLocal areaRemote work2 days per week
$22.3 - $28.8 per hour
...patient's account balance is zero. The Lead, Coding & Billing is a hands-on senior... ...day-to-day operational leadership for pre-submission billing and specialty coding activities... ...standards. - Communicate payer and regulatory updates to staff and leadership. Collaboration...RegulatoryHourly payTemporary workLocal areaImmediate startFlexible hours$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... ...alignment with the Global Regulatory Lead. Translates complex pertinent global requirements...RegulatoryTemporary workWork at officeLocal areaFlexible hours- ...new standards of care. The Global Senior Manager, IT Audit is responsible for leading and executing the global IT audit... ...leadership on technology risk, regulatory developments, and emerging... ...integralife.com. Unsolicited Agency Submission Integra LifeSciences does...RegulatoryFull timeTemporary workWork at office
- ...Sandoz International GmbH is seeking an Associate Director for Regulatory Affairs - Biosimilars in Princeton, NJ. This pivotal role involves leading regulatory strategies, managing submissions, and serving as a liaison throughout the product lifecycle. Applicants should...RegulatoryFlexible hours
- ...Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion... ...developing! About the Role Regulatory Publishing Specialist supports the preparation, formatting, compilation, and submission of regulatory documents to the US FDA via...RegulatoryWork at office
- ...A leading pharmaceutical company is seeking a Manager of Global Quality Compliance to oversee the review of manufacturing and packaging records, ensuring compliance with FDA regulations and Good Manufacturing Practices (GMP). This role requires a strong understanding of...
- ...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
$100k
...Maximus is seeking a Certification Lead to manage end-to-end certification activities, including system implementation support, audits... ...teams while driving process improvement and supporting regulatory-driven program objectives. **This is a fully remote position....RegulatoryRemote work$114.6k - $234.6k
...Job Description At a time when global technological developments and healthcare regulations are occurring and changing at an... ...Global Medical Device & Life Sciences Policy Director, you will lead regulatory policy efforts impacting our global AI-enabled, Cloud-native...RegulatoryTemporary workFlexible hours
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