US Regulatory Lead: Oncology & Neurology Submissions
O2 Technologies,Inc
O2 Technologies,Inc is seeking a regulatory affairs professional to lead submissions and regulatory strategy for oncology and neurology programs. The role emphasizes IND/NDA/BLA submissions and US regulatory compliance, requiring strong cross-functional collaboration. The ideal candidate will have a PharmD/MS/PhD or equivalent, a solid foundation in eCTD processes, and experience with regulatory intelligence and document management systems. #J-18808-Ljbffr O2 Technologies,Inc
- ...areas including immunology, oncology and neuroscience - and... ...about AbbVie, please visit us at . Follow @abbvie on... ...Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins... ...and review of regulatory submissions consistent within US and...RegulatoryFull timeLocal area
$135.62k - $203.44k
...to: Senior Director, Global Regulatory Strategy About Alexion... ...living with rare diseases. We lead with breakthrough science, deep... ...Manager, Regulatory Affairs US lead will be responsible for... ...and execution of regulatory submissions in the US (e.g. INDs, BLAs/NDAs...RegulatoryFull timeTemporary workWork at office$186.23k - $279.35k
...to: Senior Director, Global Regulatory Strategy About Alexion For... ...living with rare diseases. We lead with breakthrough science,... ...Director, Regulatory Affairs US lead will be accountable for the... ...assigned programs. Acting as submission sub-team lead for US submissions...RegulatoryFull timeTemporary workWork at office$136.51k - $204.77k
...Title: Associate Director, CMC Lead Introduction to role:... ...team pushing the boundaries of oncology through novel radioconjugates... ...IND/IMPD Readiness: Lead CMC regulatory strategy; guide and... ...and data packages for IND/IMPD submissions. API/Drug Product/Analytical...RegulatoryHourly payFull timeTemporary work- ...Counsel - Junior / Senior / Lead Job Openings Lawyer / Attorney... .../ Senior / Lead About Us Catalyst Labs is a leading... ...specialized vertical in Legal, Regulatory Compliance, and Corporate... ...impactful cases, regulatory submissions, process improvements, policy...RegulatoryContract work
$111k - $167k
...predictive, and precise. Description The Regulatory Compliance Lead is a technically grounded individual... ...and product teams to operationalize US regulatory requirements — with an eye... ...control systems for change control, submission tracking, and compliance workflows....RegulatoryFull time- ...Executive Director, Global Medical Affairs Lead, Oncology About the Company Innovative biopharmaceutical company Industry Pharmaceuticals... ...are in line with the company's strategic objectives and regulatory requirements. This pivotal role demands a leader with a...RegulatoryRemote work
- ...ManagerLead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines,... ...and data validation plans in alignment with study protocols and regulatory requirements.Oversee the design, build, and validation of clinical...RegulatoryWork at office
- ...you will be responsible for leading the design and implementation... ...in supporting selected oncology portfolio programs by engaging... ...portfolio. You will also work with regulatory agencies and health... ...~ Contributed to regulatory submission documentation such as INDs,...RegulatoryHourly payTemporary workImmediate start
$210.9k - $379.2k
...Moderna is seeking a Global Medical Lead to lead medical affairs strategy across our Oncology portfolio, spanning early... ...will interface extensively with regulatory, clinical, commercial, and external... ...Basic Qualifications) MD or non-US equivalent, PharmD, or PhD with extensive...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide- ...Vice President of Regulatory Affairs About the Company Leading biopharmaceutical firm specializing in oncology therapeutics Industry Biotechnology... ...in leading successful BLA submissions, particularly for oncology... ...deep understanding of the US regulatory landscape,...Regulatory
$288.4k
...Leader - Translational Clinical Oncology Location: Cambridge, MA,... ...and leadership boards. Lead clinical strategy... ...investigator brochures, and regulatory submissions. Contribute scientific and... ...call (***) ***-**** and let us know the nature of your request...RegulatoryLocal areaFlexible hours$192.4k - $302.39k
...DescriptionLead Counsel, Brand Attorney, Oncology Business UnitJob DescriptionAs Lead Counsel, Brand Attorney, you will... ...Unit. You will participate in US and global integrated brand team reviews... ..., including Ethics & Compliance, Regulatory and Medical Affairs, to support a...RegulatoryMinimum wageLocal areaRemote work- ...ago, CRISPR Therapeutics is a leading biopharmaceutical company... ...cardiovascular, autoimmune, oncology, regenerative medicine and rare... .... Reporting to the Head of Regulatory Affairs, you will work... ...knowledge of eCTD requirements for submission to US and ex-US regulatory...RegulatoryContract workRemote work
- ...specialized units including neurology, cardiac, bariatric,... ..., GYN/GU, orthopedics, oncology, transplant (liver and... ...including 12-lead EKGs , Lasix drips, blood... ...license required at time of submission Minimum 3 years of related... ...Why Join Us Expected 72 hours biweekly...Weekly payFull timeContract workTemporary workLocal areaImmediate startShift workNight shiftRotating shiftDay shiftAfternoon shift
- ...patients while conforming to regulatory standards and applicable laws... ...provides services in surgery, oncology, ventilators, intensive care... ...specialty clinics. Learn more about us: DMH Mission Statement The... ...Board of Psychiatry and Neurology (ABPN) and/or be certified by...RegulatoryTraineeshipWork experience placementWork at office
- ...centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal,... ...a Senior Director, Head of Marketing, US Oncology to lead the strategic and tactical marketing efforts... ...Affairs, Market Access, Sales, Regulatory, and external agencies to deliver high...RegulatoryFull timeTemporary workLive inWork at office
$168.22k - $203.84k
...Working with Us Challenging. Meaningful. Life... ...Science Liaison, Lung/GU Oncology Location Field -... ...to clinical trials. Leads major evidence read‑outs... ...HCPs in the ISR submission and execution process and... ...including compliance and regulatory guidelines Understanding...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workHome officeFlexible hoursShift work- ...seeking a Principal Statistical Programmer to lead and mentor a team, delegate tasks, and provide expert SAS support for clinical submissions. The role requires deep clinical data... ...(ISS/ISE), and uphold Vertex and regulatory standards, with eligibility for remote/hybrid...RegulatoryRemote work
$206.25k - $297.92k
...New Product Planning – Neurology ~ Location: Cambridge... ...experience to lead the commercial strategy... ...Clinical Development, Regulatory, Medical, Business Operations... ...innovative pipeline – enables us to invent medicines and... ...Neurology TAS ensuring submission of an aligned and clear...RegulatoryFull time- ...Senior Vice President, Global Regulatory Affairs About the Company... ...next-generation precision oncology therapeutics. Industry... ...hands-on approach, capable of leading the team in interactions with... ...regulatory documentation and submissions, providing strategic...Regulatory
$161.6k - $242.4k
...universe of precision oncology targets into novel areas... ...event signals and author regulatory safety reports across... ...commercialization decisions. Your Role Lead and oversee ongoing... ...in regulatory submissions for marketing license applications in the US and in EU preferred...RegulatoryFlexible hours$169.4k - $279.6k
...in the industry for over 170 years. Join us to discover a culture that is rooted in innovation... ...way for best-in-class solutions. As a Lead Architect, you will collaborate with... ..., responsible AI practices, and regulatory frameworks (EU AI Act, GDPR) Experience...RegulatoryTemporary workWork experience placementLocal area$129k - $153k
...Position Overview: \n \n Regulatory leaders who leverage regional... ...deliverables (including leading assigned tasks) while fostering... ...1 documentation required for submission and supports response to health... ...one or more key regions (EU, US, Japan)\n \n Experience working...RegulatoryWorldwideRelocation package$34.28 - $47 per hour
...Building Careers. Joining us is a chance to do important work... ...standards of care. The Lead Facilities Maintenance Technician... ...impact on product quality, regulatory compliance, and patient safety... ...integralife.com. Unsolicited Agency Submission Integra LifeSciences does...RegulatoryHourly payTemporary workFor contractorsLocal areaShift workWeekend work$206.25k - $297.92k
...Evidence (RWE) Strategy Lead, you will establish... ...evidence that drives regulatory, access and medical... ...innovative pipeline - enables us to invent medicines... ...or reimbursement submissions.Use of innovative RWE... ..., Rare Diseases, Oncology, Neurology, Ophthalmology is highly...RegulatoryFull timeLocal area$142k - $190k
...About This Role: As an External Site Lead, within our Global External Manufacturing... .... Your expertise in control strategies, regulatory compliance and CDMO management makes you... ...backgrounds, cultures, and perspectives make us a stronger and more innovative company,...RegulatoryFull timeContract workTemporary workLocal area$23.15 - $31.16 per hour
...a difference in people's lives. The Lead Medical Assistant is an allied health professional... ...and oversight for compliance and regulatory matters, referring issues to the Practice... .... Your skill and compassion can make us even stronger. Equal Opportunity Employer...RegulatoryHourly payWork at officeShift work$315k - $340k
...Olema Oncology is dedicated to developing better medicines... ...cancer and beyond. Our lead program, palazestrant (... ...you’re ready to join us at the edge of... ...Partner with Clinical and Regulatory to support inspection-ready programs and submissions Manufacturing & Commercial...RegulatoryWork at officeFlexible hours- ...Lead Clinical Data Manager A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized... ...management processes, as well as global regulatory and industry rules and guidance... ...processes and global project submissions through to approval....RegulatoryContract workFor contractorsImmediate start
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