Global Regulatory Health Authorities Lead - Submissions
NANT
ImmunityBio in Summit, NJ, seeks a Principal Specialist, Health Authorities, to shape global regulatory strategy for investigational and marketed products. You will prepare, review, and finalize Health Authority submissions and responses, ensuring compliance with local requirements. You will provide high-level expertise, oversee document control, and mentor teams while monitoring evolving Health Authority guidance to anticipate regulatory changes and support cross-functional partners. #J-18808-Ljbffr
$151.5k - $218.83k
...with demonstrated experience. Global HCP Lead, Allegra Location:... ...curiosity and your drive to make health simpler, smarter and more human... ...with global brand strategy, regulatory requirements and scientific... ...functionally and influence without authority with strong communication...RegulatoryTemporary workWorldwide- ...Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory... ...program teams to deliver submission-ready CMC content with... ...based approach. You will lead cross‑functional teams,... ...ensuring data integrity and health authority alignment. #J-18808-...Regulatory
$129k - $182k
...Veterinary Medical Lead, Global Diagnostics - Core Portfolio... ...with key animal health organizations critical... ...KOLs on development, submission, and execution of... ...Lifecycle Innovation, Regulatory Affairs, Technical Support... ...possess or obtain authorization to work in the US for...RegulatoryFull timeTemporary workWork at officeLocal areaRemote work$143.2k - $196.9k
...Initiatives and Compliance Lead 3M Health Care is now Solventum At Solventum... ...Compliance: Work with regulatory and compliance teams to translate... ...Assistance May be authorized Must be legally authorized... ...veteran status. Solventum Global Terms of Use and Privacy Statement...RegulatoryH1bLocal areaRemote workRelocation packageFlexible hours- ...in Rahway, NJ seeks an experienced Regulatory Affairs professional to develop and... ...The role focuses on CMC dossiers, global submissions, and coordination with manufacturing... ...regulatory conformance. The candidate will lead documentation, authoring, and reviews for regulatory...Regulatory
- ...AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada. You will develop and implement strategic and tactical... ...FDA, prepare briefing packages, and coordinate regulatory submissions and responses. The role requires cross-functional...Regulatory
- ...that solve serious health issues today and address... ...The Senior Manager Regulatory Affairs, Global Reg Strategy US &... ...(Global Regulatory Lead (GRL), Associate Director... ...of regulatory submissions consistent within US... ...response to Health Authorities during application review...RegulatoryWork at officeRemote work
- 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
- ...Associate Director/Director-Global Clinical Pharmacology 1... ...role as clinical technical lead on global Phase I-III and other... ..., medical monitors, regulatory authorities, medical affairs, commercial... ...reports required for regulatory submissions MAJOR RESPONSIBILITIES AND...RegulatoryWorldwide
$130k - $164.6k
...Therapeutics seeks a Senior Manager to lead global clinical regulatory strategy and execution for drug... ...markets. This role oversees IND submissions, clinical trial applications, regional... ...cross-functional teams, CROs, and health authorities on clinical trial applications...Regulatory- ...Position Summary The Principal Specialist, Health Authorities will assist in the development of global clinical regulatory strategy for investigational and marketed products... ...preparation, review, and finalization of submission packages and responses to Health Authorities...RegulatoryLocal areaMonday to FridayShift work
$144.16k - $216.24k
...striving for a world where 'Health for all Hunger for none’... ...there’s only one choice.Global Consolidated Customer Data & AI Lead The Global Consolidated... ...terms, and applicable regulatory requirements in... ...influence without direct authority in a global matrix environment...RegulatoryLocal area$187.95k - $258.43k
...company putting everyday health in the hands of... ...Otrivin, and Centrum - lead in resilient and growing... ...key requests from local, global, and external stakeholders... ...influencing without direct authority, and converting complex... ...we meet certain regulatory and reporting obligations...RegulatoryFull timeLocal area3 days per week$190.8k - $300.3k
...SummaryThe Director, Launch Lead is a key member of the Global Launch Excellence and... ...priority our Company's Animal Health product launches. The... ...Development: R&D Project Lead.Regulatory: Global Regulatory... ...influence and without direct authority.Strong understanding of...RegulatoryFull timeFor contractorsLocal areaFlexible hours- ...CMC organization provides regulatory expertise related to CMC activities... ...the organization develop global regulatory CMC strategies... ...documents to support Health Authority submissions. The team also supports... ...including participating / leading HA meetings with support);...RegulatoryFull time
$84.5k - $162k
...Senior Associate, Regulatory Affairs Submission Management - Hybrid Full-time... ...Salary Max: 162000 Workday Global Grade: 16 Compensation:... ...that solve serious health issues today and address the... ...post-marketing regulatory authority applications. This individual...RegulatoryFull timeWork at officeLocal areaRemote work- MSD is seeking a Senior Principal Scientist/Director, Regulatory Liaison, to lead global regulatory strategy for General Medicine programs with a... ...provide regulatory advice to EDT/PDT, and drive strategic submissions worldwide while collaborating across GRACS, clinical...RegulatoryWorldwide
- ...Statistical Programmer in East Hanover, NJ. You will lead a team of programmers across global clinical programs, driving efficiency, quality, and... ..., Data Management, and clinical teams to support regulatory submissions and decision making, with a focus #J-18808-Ljbffr...Regulatory
- Opella seeks a Global HCP Lead to advance our multi-channel HCP marketing strategy across a global footprint. You will define the global... ...medical professionals, and ensure alignment with brand and regulatory requirements. You will mentor teams, translate scientific insights...Regulatory
- Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities and clinical trial disclosures... ...will collaborate with cross-functional teams and Health Authorities to ensure compliant labeling and transparency....RegulatoryRemote job
- ...seeking a Director of Biostatistics to lead the statistical design and analysis for... ...You will shape trial designs to support regulatory approvals and market access while... ...functional teams, and interaction with health authorities. #J-18808-Ljbffr Bristol-Myers Squibb...Regulatory
- ...of Solid Tumors, Global Medical Affairs Oncology... ...solve serious health issues today and... ...Medical Affairs will lead and oversee the... ...clinical trials, regulatory interactions, and... ...support regulatory submissions and interactions with health authorities. Partner with commercial...RegulatoryTemporary work
- ...Osmo, a digital olfaction company based in Elizabeth, NJ, is seeking an experienced regulatory professional to own interpretation and implementation of global regulatory requirements for fragrance ingredients and finished products. You will advise cross-functional teams...Regulatory
- ...Director, Americas Region Lead, Diversity & Inclusion... ...the job Join our Global Diversity & Inclusion... ...the charge in advancing health equity and driving meaningful... .... Stay current on regulatory requirements in the... ...makers (Local health authorities, TransCelerate, PhRMA,...RegulatoryLocal area
$207.49k - $251.43k
...Generation in Medical Affairs will lead the strategic development and... ..., Clinical Operations, Regulatory, HEOR, Access & Value) and with... ..., observational research, and health outcomes studies. Critically... ...stakeholders. Understanding of global healthcare systems and academic...RegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...HireLifeScience seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies in Immunology. You will be the global point of contact on assigned projects, interacting with FDA, EMA, and affiliates to optimize labeling and shorten...RegulatoryWorldwide
$160k - $200k
## Lead Project Manager, AviationApplylocations:... ...id: 6046**TYLin** is a globally recognized, full-service... ...alongside airport authorities, public agencies, contractors... ..., contractors, regulatory agencies and project stakeholders... ...comply with all local health authority, legal or...RegulatoryContract workFor contractorsWork at officeLocal area$158k - $209k
...embecta is a global medical device company... ...Global Medical Safety Lead serves as the... ...excellence, ensure regulatory compliance and support... ...regulatory submissions and responses related... ...Effects Analysis (FMEA) Health Risk Assessments (... ...experience authoring, reviewing, or contributing...RegulatoryWork at officeWorldwide3 days per week- ...Kite Pharma in the United States seeks a Director, Submission Project Management to lead strategic and operational planning for major regulatory submissions (BLAs, sBLAs, NDAs) across Clinical Development, Regulatory Affairs, Data Management, and Biostatistics. The role...Regulatory
- AbbVie in Florham Park, NJ seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. You will develop and implement plans, coordinate FDA interactions, and guide submissions across therapeutic areas. Hybrid schedule with in-office and remote days...RegulatoryWork at officeRemote work
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