Global Regulatory Strategist, Oncology — Lead Submissions
Initial Therapeutics, Inc.
Initial Therapeutics, Inc. is seeking a Global Regulatory Strategist in Morristown, NJ to develop regulatory strategies in oncology. This role involves collaboration with clinical and commercial teams and ensuring timely submissions to Health Authorities. The ideal candidate has substantial experience in Regulatory Affairs and a deep understanding of clinical development. Join a mission-driven team committed to improving lives through innovative therapeutics. #J-18808-Ljbffr Initial Therapeutics, Inc.
$120k - $150k
Shionogi Inc. is looking for a Manager, Regulatory Affairs - Global Development in Florham Park, NJ. This role involves leading regulatory activities for assigned products, managing submissions including INDs and NDAs, and ensuring compliance with FDA regulations. The position...Regulatory- Job title Global Regulatory Strategist Grade : L3 Location : Morristown, NJ About the job... ...regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the... ...within remit, as needed Regulatory Submissions & Operations Leads submission...RegulatoryLocal area
- A global health company is seeking a Global Regulatory Lead to support the regulatory strategy for new drugs and medical devices. This role involves managing submissions like INDs and NDAs, reviewing product labeling for compliance, and offering regulatory insights throughout...Regulatory
- Sanofi is seeking a Global Submission Lead to oversee regulatory submission planning and coordination. This role involves ensuring that all submissions meet regulatory standards and are delivered on time. The successful candidate will collaborate across teams and manage...Regulatory
$122.25k - $176.58k
...Job title: Global Submission Lead ~ Location: Morristown, NJ / Cambridge, MA. About the job As Global Submission Lead within... ...for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities for...RegulatoryWorldwideFlexible hours- Sanofi in Morristown, NJ seeks a Global Regulatory Strategist to lead regulatory efforts in oncology product development. Candidates should have a BS/BA in a scientific field or an advanced degree, with significant experience in the pharmaceutical industry, particularly...Regulatory
- ...'s be those people. As Global Labeling Strategist within our R&D team, you will... ...is responsible for leading or co-leading the development... ..., ensuring alignment with regulatory requirements and Sanofi's... ...value. Assist in labeling submissions, regulatory queries, and...RegulatoryLocal area
- ...Global Regulatory Lead Estimate start date July 7th At LEO Pharma, our mission transcends the conventional. We're on an ambitious path... ...international markets Plan and execute global regulatory submissions (e.g., MAA/NDA, CTA/IND, label extensions, PIP/PSP) Review...RegulatoryWorldwide
- Sanofi is seeking a Global Project Head (GPH) in Ophthalmology to oversee development activities and lead cross-functional teams. The GPH will drive strategic initiatives from clinical studies to regulatory submissions. Ideal candidates should have a Medical Doctor or...Regulatory
- A global biopharmaceutical company is looking for an Associate Director of Regulatory Affairs to lead the regulatory strategies for Chemistry, Manufacturing, and Controls (CMC). You will prepare and manage regulatory submissions while collaborating with internal departments...Regulatory
$111k - $130k
..., Minerals & Supplements (VMS) market globally.Our mission is to bring health in people... ...at .## ***About the Job***The Global Regulatory Lead supports the regulatory strategy for... ...It involves preparing and managing key submissions like INDs and NDAs while coordinating...RegulatoryWorldwide$120k - $180.31k
Global Regulatory CMC Lead page is loaded## Global Regulatory CMC Leadlocations: Morristown, NJtime type: Full timeposted on: Posted Todaytime... ...product development timelines* Manage regulatory submissions across major markets (FDA, EU, etc.)* Provide expert guidance...RegulatoryWorldwide$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$119.7k - $223.3k
Novartis Farmacéutica is seeking a Senior Manager, Regulatory Affairs CMC in East Hanover, NJ, to lead global regulatory strategy and ensure compliance throughout the product lifecycle. Candidates should have over 5 years of experience in regulatory affairs, excellent...Regulatory- ...US HEOR Oncology & Rare Team Lead Location: Cambridge (US) / Morristown (US) / Hybrid (3 days onsite... ...positioning, ensuring alignment with Global HEVA strategy Partner with... ...management Ensure scientific rigor and regulatory compliance across all HEVA research activities...Regulatory
- A prominent global healthcare firm in Morristown, NJ, is seeking an experienced Global Regulatory CMC Lead to oversee the regulatory strategy for OTC medicinal and nutritional products. This role requires partnership with cross-functional teams to ensure successful product...Regulatory
$206.25k - $297.92k
...Job Title: US HEOR Oncology & Rare Team Lead Location: Cambridge (US) / Morristown (US) / Hybrid... ...positioning, ensuring alignment with Global HEVA strategy Partner with... ...management Ensure scientific rigor and regulatory compliance across all HEVA research activities...Regulatory- ...therapeutic areas – immunology, oncology, neuroscience, and eye care –... ...& Outcomes Research (HEOR) leads the strategic development &... ...of pipeline development and global launch Proven leadership skills... ...knowledge of the global regulatory, HTA and PR&A landscape, as well...RegulatoryTemporary workWork experience placementLocal area
- ...peers and cross-functional teams. Maintain solid knowledge of Regulatory Agency organizations. Apply knowledge and experience to increasingly... ...stakeholder timelines and objectives. Develop and communicate submission strategies for the project team, including strategies for...RegulatoryWork at office
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...Regulatory
- Sanofi is seeking a US Regulatory Strategist in Morristown, NJ, to play a pivotal role in shaping... ...Health Authority engagements and leading submission teams for compliant filing timelines... ...biopharma projects aimed at improving lives globally. Competitive salary and benefits...Regulatory
$122.25k - $176.58k
**Job title:** US Regulatory Strategist* **Location:** Morristown, NJ**About the... ...as a key member of the Global Regulatory Team (GRT) and strategic... ...to the Global Regulatory Lead (GRL). You will leverage... ...assigned products, leading submission teams to ensure NDA/BLA/MAA/...RegulatoryLocal area- ...several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and... ...Tok. Job Description The Senior Counsel, Global Commercial Legal - U.S. Market Access and... ...a broad range of legal, compliance, and regulatory issues, with a primary focus on federal...RegulatoryTemporary workWork at office
$297.59k - $360.6k
...hiring an Executive Director, Global Program Leader, Pumitamig.... ...and will be responsible for leading a portion of the Pumitamig development... ...within the HOCT (Hematology, Oncology & Cell Therapy) Global... ...therapeutic advances, and evolving regulatory, patient advocacy and market...RegulatoryHourly payPermanent employmentFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- A leading pharmaceutical company in Morristown, NJ is seeking an experienced professional to manage its medical affairs projects. This... ..., overseeing project execution, and ensuring compliance with regulatory requirements. The ideal candidate will have over 5 years of...Regulatory
$275.63k - $334k
...us . The Director, Global Clinical Physician sits... ...Clinical Development Lead, designs and develops... ...science in order to meet regulatory and disease strategy... ...reports, briefing books and submission documents to support... ...Physician - Late Oncology (GI) Company: Bristol...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workWorldwideFlexible hoursShift work$178.5k - $257.83k
...Job Title: Sr. AI Driven Innovations Lead Location: Morristown, NJ About the... ...data processing, analysis, and regulatory submission, ensuring alignment with Sanofi's broader... ...organization. We are an innovative global healthcare company with one purpose: to...RegulatoryTemporary workWork experience placementFlexible hours$70k - $130k
A biotechnology company is seeking a Senior Specialist in Regulatory Operations to manage regulatory submissions across their development pipeline. The role involves leading submission management and ensuring compliance while working closely with cross-functional partners...RegulatoryRemote jobWork at office$75k - $108.33k
Job Title: Global Submission Associate Location: Morristown, NJ About the job The Global Submission... ...Submission Managers and Submission Leads to support the publishing and delivery... ...review regional submission documentation to regulatory health authorities according to ICH /...RegulatoryFull timeLocal area$85k - $115k
Joulé is seeking a Regulatory Compliance Specialist in Pine Brook, NJ. This full-time role involves managing compliance across complex regulations, developing strategies for packaging, and conducting regulatory risk assessments. Ideal candidates have a Bachelor’s degree...RegulatoryFull timeRemote work
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