Global Regulatory Submissions Lead
$160k - $175kAscendis Pharma A/S
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 skills. This role offers a dynamic environment for growth, adherence to regulatory standards, and collaboration with cross-functional teams. The estimated salary range is $160K-$175K/year. #J-18808-Ljbffr
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Submissions Lead in Princeton, NJ vacancy
$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...RegulatoryAscendis Pharma
Princeton, NJ6 hours ago- ...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...Regulatory
Artech Information System LLC
Lawrence, NJ5 hours ago - ...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
Jobr
Princeton, NJ5 hours ago $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 officeJobleads-US
Princeton, NJ6 hours ago$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 workBristol-Myers Squibb
Princeton, NJ5 hours ago- ...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
Otsuka Pharmaceutical Co., Ltd
Princeton, NJ5 hours ago - ...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
Astrix Inc
Princeton, NJ5 hours ago - ...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
Jobleads-US
Princeton, NJ5 hours ago $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
...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 hoursOtsuka America Pharmaceutical Inc.
Trenton, NJ4 days ago$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 hoursOtsuka Pharmaceutical Co., Ltd.
Princeton, NJ3 days ago$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 workBristol-Myers Squibb Company
Princeton, NJ4 days ago$297.59k - $360.6k
...BMS is hiring an Executive Director, Global Program Leader, Pumitamig. This individual... ...Pumitamig, and will be responsible for leading a portion of the Pumitamig development book... ...area therapeutic advances, and evolving regulatory, patient advocacy and market access...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workBristol-Myers Squibb Company
Princeton, NJ1 day ago- ...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
ACADIA Pharmaceuticals
Princeton, NJ6 hours ago $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 placementINTEGRA LIFESCIENCES HOLDINGS CORP
Plainsboro, NJ3 days ago$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 placementIntegra LifeSciences
Plainsboro, NJ2 days ago$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 hoursOtsuka America Pharmaceutical Inc.
Princeton, NJ1 day ago- ...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
Integra LifeSciences
Princeton, NJ5 days ago - ...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
Sandoz International
Princeton, NJ1 day ago - ...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
Hengrui Pharma
Princeton, NJ4 days ago - ...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
Jobleads-US
Plainsboro, NJ5 hours ago - ...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...
Sun Pharmaceutical Industries, Inc.
Princeton, NJ5 hours ago $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...RegulatoryScorpion Therapeutics
Cranbury, NJ1 day ago- ...A global pharmaceuticals company is seeking a CDMO Strategic Sourcing Director to lead the development and execution of sourcing strategies for CDMOs. This role involves... ..., and ensuring compliance with quality and regulatory standards. The ideal candidate will have extensive...Regulatory
Otsuka Pharmaceutical Co., Ltd
Princeton, NJ6 hours ago $100k - $145k
...opportunity to join AXIS Capital - a trusted global provider of specialty lines insurance... ...a senior professional responsible for leading the strategy, execution, and continuous... ..., deviations, exception pages) based on regulatory requirements, timing considerations, and...RegulatoryWork at office3 days per weekAXIS Capital
Princeton, NJ10 days ago$165k - $175k
...Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations... ...handled in accordance with global/local regulatory requirements and company policies.... ...that support on time and appropriate ICSR submissions Provides pharmacovigilance expertise...RegulatoryTemporary workLocal areaFlexible hoursAscendis Pharma
Princeton, NJ6 days ago- ...Title : Lead Associate- OTC Department : Regulatory Affairs Reports To : Team Lead -Regulatory Affairs... ...manuscripts, review and approval of submission artworks and private label), Bill... ...submissions to the FDA Coordinate with global RA team to facilitate post...RegulatoryContract work
$185.8k - $296.1k
...Munich Re Specialty - North America, a leading specialty insurance provider dedicated to... ...coverages. With the financial strength and global resources of our A+ Superior (A.M. Best)... ..., including policy structure, legal and regulatory considerations, and underwriting...RegulatoryTemporary workMunich Re
Princeton, NJ3 days ago$97.5k - $126.5k
...Ramboll is a global architecture, engineering, and consultancy company. As a foundation‑... ...Princeton, NJ office. We are hiring for a Senior Lead Consultant to join the Mergers &... ...environmental compliance support across regulatory programs such as hazardous waste, wastewater...RegulatoryFull timeWork at officeLocal areaFlexible hoursRamboll Group A/S
Princeton, NJ5 hours ago- ...needs, we are dedicated to helping people lead longer and healthier lives. We are... ...pricing trends, reimbursement policies, and regulatory requirements Your role involves developing... ...quarterly PHS Pricing and sign-off for submission to the wholesaler and provide floor...RegulatoryContract workWork experience placement
Dr Reddy's Laboratories Limited
Princeton, NJ21 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Submissions Lead. Be the first to apply!
