Submissions & Regulatory Intelligence Lead
6084-Janssen Research & Development, LLC Legal Entity
Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within IDAR to provide expert guidance on clinical data submission requirements and regulatory strategies across multiple countries.
You will serve as the primary point of contact for data management, statistical programming, and global regulatory affairs, ensuring SDTM/ADaM readiness and compliance with RHA guidance.
#J-18808-Ljbffr- ...Scientist to serve as a Drug Metabolism and Pharmacokinetics (DMPK) submission expert. This leader will support our development pipeline to... ...and through life-cycle management. The role influences regulatory filings, labeling discussions and approvals as part of the DMPK...Regulatory
$129k - $153k
...worldwide.Position Overview: Regulatory leaders who leverage... ...regulatory deliverables (including leading assigned tasks) while fostering... ...documentation required for submission and supports response to... ...and competitive regulatory intelligence. Ensures on-time execution of...RegulatoryIntelligenceFull timeWorldwideRelocation package$117k - $201.25k
...more at We are searching for the best talent for a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR... ...checking for IDAR. The position may serve as the lead of the Submission Center of Excellence, serving as POC for...RegulatoryIntelligenceTemporary workLocal areaImmediate start3 days per week- ...Eight Eleven Group is seeking a Regulatory Program Manager to lead operational execution of regulatory strategy for its Oncology portfolio. The... ...cross-functional teams to ensure timely, high-quality submissions. The role requires deep experience in global regulatory...Regulatory
- ...Feasibility Lead At ICON Strategic Solutions, you will work... ...-of-care review, and regulatory and start-up timeline mapping... ...performance data, external intelligence sources, and direct site and... ...requirements, and country-level submission and approval timelines....RegulatoryIntelligenceRemote jobPrivate practiceWorldwideFlexible hoursShift work
- CSL Plasma in King of Prussia, PA is seeking a Senior Manager, Regulatory Submission. This hybrid role teams with Global Regulatory Submission Management to ensure timely, high-quality regulatory submissions across markets. You will coordinate with Regulatory, Project Management...Regulatory
- .... in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and Bioconjugates... ...related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions. #J-18808-Ljbffr...Regulatory
- ...Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide... ...will lead cross‑functional regulatory activities, prepare submissions, and ensure compliance with health authority standards while...Regulatory
$136.1k - $252.8k
...a Director, Product Portfolio - Life Sciences to lead portfolio strategy, investment planning, and product... ...will help shape the future of a next-generation regulatory intelligence, data management, workflow, and submission platform that enables customers to move faster,...RegulatoryIntelligenceFull timeLocal area- Merck & Co., Inc. is seeking a Principal Scientist to lead biologics process development, scale-up, and tech transfer for late... ...global sites. The candidate will drive PPQ readiness, regulatory submissions, and continuous improvement in sterile manufacturing, with a...Regulatory
- ...Phase 3 development and label submission. You will integrate a Market... ...Services, etc.) Experience leading diverse teams and working... ...Functional Collaboration, Customer Intelligence, Global Market, Go-to-Market... ..., Pricing Strategies, Regulatory Compliance, Strategic Change...RegulatoryIntelligenceLocal area
$96.68k - $120.85k
...this position, the selected candidate will lead and support multidisciplinary teams... ...review technical deliverables, and support regulatory and client communications. You will also... ...and finalization through final submission of technical documents, including regulatory...RegulatoryFull timeWork at office- ...CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This... ...Global Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates have 5+ years in...Regulatory
$194k - $334.65k
...clinical development. The role leads assigned studies and... ...and high-quality clinical and regulatory deliverables.Key Responsibilities... ...content to regulatory submissions, briefing packages, health authority... ....Comfort using artificial intelligence and digital tools to improve...RegulatoryIntelligenceLocal areaImmediate start- ...ICON is a global healthcare intelligence and clinical research organisation... ...that support study quality, regulatory readiness and client success... ...CRO in drug development. Lead, motivate and advise project... ...adaptive design, regulatory submission and post-marketing studies....RegulatoryIntelligenceLive inRemote work
$94.88k - $151.8k
...Requisition #: 76557The Role at a GlanceThe Lead Talent Acquisition Governance &... ...optimize future events and partnerships.Market Intelligence, Pipeline Strategy & Talent... ...Experience in risk mitigation, audit support, regulatory compliance, and data-driven measurement...RegulatoryIntelligenceWork experience placementWork at officeRemote workWork from homeRelocationRelocation package- ...HireLifeScience seeks an Associate Director, Regulatory Affairs – Power Platform Solutions Specialist to technically lead Power Apps, Dataverse, and Power Automate implementations supporting regulatory requirements. You will configure data models, automate workflows,...Regulatory
$164k - $282.9k
...insights to support clinical programs and regulatory submissions. This Director role, sitting on the... ...Tumor Oncology team, will direct and lead efforts to bring innovative Data Science... ...field of biotechnology, artificial intelligence, omics, or real-world evidence, or 8 years...RegulatoryIntelligenceTemporary workLocal areaRemote work- ...Description The Associate Director, Geography Lead oversees day-to-day data-management... ...Trial Operation) processes and local regulatory requirements; drive consistent execution... ...improve outcomes, and support consistent, submission‑ready outputs across studies. Strategic...RegulatoryLocal area
- ...Corporation seeks a Senior Managing Consultant in air quality compliance & permitting to lead complex projects within Ramboll's Environment & Health division. You will guide regulatory interpretation, emissions estimation, and air permit preparation for diverse industries...Regulatory
- ...multi location workforces and sophisticated regulatory requirements, requiring customized... ...within current accounts.Engage with warm leads from marketing, channel partners, and existing... ...QualificationsAdaptability & Emotional Intelligence -- Ability to adjust to changing sales...RegulatoryIntelligence
- ...in Spring House, PA seeks a cGMP Compliance and Investigations Lead to drive deviation investigations and CAPA programs supporting... ...inspection-ready. The role requires leading complex investigations, regulatory awareness (FDA/EMA), and strong documentation practices, with a...Regulatory
- ...world leader in health care, seeks a cGMP Compliance and Investigations Lead for its Innovative Medicine team in Spring House, PA. You will guide investigations, CAPA development, and regulatory readiness across QA/QC and manufacturing functions. The role requires in-...Regulatory
$159k - $274.85k
...tomorrow. Our Immunology team leads in the development of... ...and high-quality clinical and regulatory deliverables across immune-mediated... ...content to regulatory submissions, briefing packages, health authority... .... Comfort using artificial intelligence, digital tools, and emerging...RegulatoryIntelligenceLocal areaImmediate start- ...headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and... ...secure timely approvals. Your leadership will guide global submissions, change controls, and regulator interactions, ensuring compliant...Regulatory
- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...Regulatory
- Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs focused on cardiovascular metabolic areas. You will ensure optimal labeling and the fastest time to approval by engaging...RegulatoryWorldwide
- Scorpion Therapeutics seeks an Executive Director of Regulatory Affairs Liaison in General Medicine to lead global regulatory strategy for ophthalmology... ...regulatory leadership experience, including NDA/BLA submissions, and a proven track record of delivering regulatory...Regulatory
$210.4k - $331.1k
....g. QSP, AI/ML) for key development and regulatory decisions.This role provides strategic leadership... ...The Senior Director, Group Leader will lead a team of QP2 scientists and serve as a... ...(e.g., INDs, CSRs, CTD modules, NDA/BLA submissions)Ensure delivery of high-quality clinical...RegulatoryFull timeFor contractorsLocal areaFlexible hours$1,000 per month
...Support campaign briefing, creative ticket submission (Wrike), and QC across email, direct... ...performance tracker.Conduct competitive intelligence - Monitor competitor products, messaging... ...you’ll have opportunities to give back, lead, and make a difference.1 company-paid Volunteer...IntelligenceRotational programFull timeTemporary work
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