Global Regulatory Health Authorities Lead - Submissions
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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 nant
$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$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
- 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
- ...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
$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$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- 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
- ...that solve serious health issues today and address... ...Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada... ...(Global Regulatory Lead (GRL), Associate... ...review of regulatory submissions consistent within US... ...response to Health Authorities during application review...RegulatoryWork at officeLocal areaRemote work
- ...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
- ...Manager/Associate Director, Regulatory Affairs CMC to define global CMC regulatory strategies and deliver submission-ready content. You will... .... Responsibilities include leading development of Global CMC regulatory... ...the primary liaison with Health #J-18808-Ljbffr Shionogi...Regulatory
- 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
$187.6k - $257.95k
...: Job Description 3M Health Care is now Solventum... ...businesses. This role leads the development of the... ...Strategy & Vision Lead the global Digital Dentistry... ...Scientific Education, Quality, Regulatory and Regional teams.... ...Assistance: Not authorized Must be legally authorized...RegulatoryH1bRemote workRelocation packageFlexible hours- ...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
- ...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$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- ...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
- 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
$213.16k - $293.09k
...consumer company putting everyday health in the hands of millions. In just... ...Theraflu, Otrivin, and Centrum - lead in resilient and growing categories... ...culture.About the RoleThe Wellness Regulatory Lead is responsible for executing global regulatory strategies for key wellness...RegulatoryFull timeWork at office$148.65k - $204.39k
...consumer company putting everyday health in the hands of millions. In... ..., Otrivin, and Centrum - lead in resilient and growing categories... ...strong partnerships across global and local stakeholders to drive... ...information ensures we meet certain regulatory and reporting obligations and...RegulatoryFull timeWork at officeLocal areaShift work- ...Rahway, NJ, seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to craft and execute worldwide regulatory strategies... ...on Immunology development programs. You will serve as the global single point of contact on project teams and independently interact...RegulatoryRemote jobWorldwide
- ...and continuously improve the Health, Safety, Environment (HSE)... ...organization. Implement and maintain global HSE and Operational... ...compliance measures. Coordinate with regulatory authorities and facilitate external... ...and mitigation strategies. Lead incident and accident...RegulatoryContract workFor contractorsFor subcontractorLocal area
- ...Launch Acceleration and Regulatory Enablement Lead ~ Location:... ...and delivers regulatory submission and obtains authorizations – our mission is to create... ...You will work across all Global Business Units and submission... ...Monitor evolving health authority expectations,...RegulatoryShift work
$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
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