Global Immunology Regulatory Lead - Principal Scientist
MSD Malaysia
Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs. You will be the sole global contact, coordinating with FDA/EMA and regional affiliates to optimize labeling and speed approvals. The role requires proactive leadership, strong communication, and extensive experience in regulatory affairs across multiple indications and external partners. Immunology background preferred. #J-18808-Ljbffr MSD Malaysia
$231.9k - $365k
...in the lives of people globally. With our varied pipeline of oncology, immunology, vaccines, biologics,... ...collaborative team of scientists (12 anatomic pathologists... ...including:An industry-leading suite of on-site in... ...studies, and generation of regulatory strategy and...PrincipalRegulatoryFull timeFor contractorsLocal area- Merck seeks a Principal Scientist to lead the Analytical Commercialization Technology group at Rahway, NJ and West Point, PA, driving late-stage... ...oversee method development and validation, contribute to regulatory submissions, and collaborate across regulatory, research,...PrincipalRegulatory
$173.2k - $272.6k
Job Description The Director (Principal Scientist), Global Regulatory Liaison reports to the Executive Director... ...their assigned projects within the Immunology Therapeutic Area. The individual... ...expert advice as the Global Regulatory Lead to Product Development Teams and...PrincipalRegulatoryFor contractorsLocal areaRemote workWorldwideRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...Therapeutic Area Leader for Immunology, overseeing the... ...deep understanding of regulatory expectations for immunology... ...that support global clinical development,... ...Compound Leaders, and scientists across NDS and/or Preclinical... ..., and proactively lead internal cross-departmental...PrincipalRegulatoryFull timeFor contractorsLocal areaFlexible hours$255.8k - $402.7k
...opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical... ...therapeutic areas as part of a global team. Primary... ...modeling and simulation, regulatory affairs, and global clinical... ...development strategyTaking a lead role in developing and executing...PrincipalRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$190.8k - $300.3k
...DescriptionDescriptionThe Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to... ...with a specific focus on Immunology development programs. The... ...time to approval by global regulatory agencies.You... ...as the Global Regulatory Lead to Product Development...PrincipalRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$173.2k - $272.6k
...people and animals.We are seeking a Principal Scientist to join our Analytical Commercialization... .... This is an exciting opportunity to lead a highly collaborative team of... ...Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to...PrincipalRegulatoryFull timeFor contractorsLocal areaFlexible hours$156.9k - $247k
Job DescriptionAssociate Principal Scientist/Associate Director, V&I Outcomes Research, HIVRole... ...the V&I organization, which includes Global Medical and Scientific Affairs as well... ...access and provides input into clinical, regulatory, payer/access, marketing and evidence-...PrincipalRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$96.68k - $120.85k
Company DescriptionRamboll is a global architecture, engineering,... ...the selected candidate will lead and support multidisciplinary... ...technical deliverables, and support regulatory and client communications.... ...and mid-level Geological Scientists and contribute to the development...RegulatoryFull timeWork at office- Johnson & Johnson Innovative Medicine is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This hybrid role... ..., PA. You will drive regulatory strategy, contribute to global submissions, and collaborate across global teams to enable...Regulatory
$156.9k - $247k
...lifecycle management. This person will lead several Human Factors scientists to perform and manage human... ...to ensure compliance with US and global regulatory policies/guidance for all combination... ...Responsibilities and Activities: The Principal Scientist is responsible for...PrincipalRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...and Development division, quantitative scientists, in partnership with other subject matter... ...tools to enable the discovery, development, regulatory approval, manufacturing, and marketing... ...for the benefit of patients and global human health Statisticians in the Clinical...PrincipalRegulatoryFor contractorsWork experience placementLocal areaRelocationVisa sponsorshipFlexible hoursShift work$255.8k - $402.7k
...opportunity for a physician-scientist to join our group as a- Principal Scientist (Clinical... ...therapeutic areas as part of a global team. Primary... ...modeling and simulation, regulatory affairs, and global clinical... ...development strategy Taking a lead role in developing and executing...PrincipalRegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...DescriptionJob Description Summary: Principal Scientist/Director, Biologics Drug... ...a team of scientists, leads high-impact process development... ...characterization, ensuring regulatory compliance, collaborating across... ...that directly support global manufacturing and regulatory...PrincipalRegulatoryFull timeContract workFor contractorsLocal areaFlexible hours$71.9k - $113.2k
Associate Scientist, Process Analytics Lab Lead, Biologics Drug Substance Commercialization Join Our Team as... ...with safety, environmental, quality, regulatory, and Process Safety Management... .../2026 Our Company Our company is a global health care leader with a diversified...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$260.3k - $409.7k
...and related conditions. The Principal Scientist (Clinical Director) must have... ...teamwork. As part of the global team, you will collaborate with... ...and biomarker plans for Lead Optimization programs, early... ...metabolism, modeling and simulation, regulatory affairs, and global clinical...PrincipalRegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- MSD Malaysia is seeking a Principal Scientist (Clinical Director) in Translational Medicine/Early... ...record. The successful candidate will lead cross‑functional early development activities... ...across discovery, pharmacology, regulatory, and clinical teams to advance #J-1880...PrincipalRegulatory
$173.2k - $272.6k
...a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics... ...(DMPK) group. The Principal Scientist will be a key... ...will author source reports and regulatory documents in support of filings... ...Experience working as a DMPK lead on discovery teams advancing...PrincipalRegulatoryFull timeFor contractorsLocal areaFlexible hours- Johnson & Johnson Biologics Discovery in Spring House, PA seeks a Principal Scientist, Protein Purification, Team Lead to guide a multidisciplinary group delivering purified antibodies, multispecifics, and other biologics for preclinical studies. You will set purification...Principal
$282.2k
...Senior Principal Scientist position leading clinical research strategy and execution for oncology drugs across all... ...Responsible for study design, trial management, regulatory submissions, and cross-functional collaboration within a global healthcare organization....PrincipalRegulatory- ...life while championing patients every step of the way. Learn more at We are searching for the best talent for Principal Scientist, Protein Purification, Team Lead in Spring House, PA., Purpose: At Johnson & Johnson Biologics Discovery, we work in a fast-paced R&D...PrincipalLocal area
- ...America Job Description: Immunology Clinical Scientist Intern Our expertise in Innovative... ..., medical, operational, regulatory, and other functional disciplines in a global matrix environment. The... ...presentation skills Ability to lead peers, project teams and...RegulatoryFull timeInternshipH1bLocal areaRemote work
$168k - $199k
...integrity, including ongoing review of blinded data \n May lead development of Clinical Development Program \n Contributes to... ...meeting presentations and peer-reviewed publications, and all regulatory submission documents \n Manages the process and liaisons required...PrincipalRegulatoryRelocation package- Role Principal Scientist in High-Content Imaging within Johnson & Johnson's Innovative Medicine division, focusing on advancing therapeutic discovery in Immunology, Neuroscience, and Oncology. Responsibilities include developing, validating, and deploying complex high-...Principal
- ...help shape the future of our Immunology portfolio.We are seeking a Senior... ...of Search & Evaluation to lead strategic sourcing and... ...assets, coordinating clinical, regulatory, commercial, and market access... ...CSL BehringCSL Behring is a global biotherapeutics leader driven...RegulatoryFull time3 days per week
- Scorpion Therapeutics seeks an Executive Director of Regulatory Affairs Liaison in General Medicine to lead global regulatory strategy for ophthalmology programs, with oversight of retinal disease indications and external representation. The role requires extensive drug...Regulatory
$117k - $201.25k
...Innovative Medicine Research & Development LLC, a Johnson & Johnson company, is recruiting for a Principal Scientist, R&D Data, Data Science & Artificial Intelligence (DDSAI) - Immunology . This position will be located at one of our offices in either Cambridge, MA; Spring...PrincipalTemporary workLocal areaRemote work$117k - $201.25k
...Innovative Medicine is recruiting for a Principal Scientist, AI & Autonomous Discovery Systems, to... ...cardiovascular and metabolic disorders, immunology, neuroscience, and infectious disease.... ...discovery within the pharmaceutical industry.Lead cross-functional work across data...PrincipalFull timeTemporary workLocal areaRemote work- ...Therapeutic Area Leader (TAL) to drive immunology programs across discovery to post-marketing... ..., integrating complex science with regulatory strategy. You will mentor Compound Leaders... ...nonclinical development plans, and shape global risk assessments and submissions, collaborating...Regulatory
- CSL in the United States is seeking a Principal Medical Writer to set the medical writing... ...Clinical Development, ensuring high-quality, regulatory-aligned deliverables. The role oversees... ...submission plans, and collaborates with global teams and regulatory authorities to...Regulatory
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