Senior Scientist, CMC Regulatory - Drug-Device Combinations
Johnson & Johnson Co.
Johnson & Johnson Innovative Medicine in the United States is seeking a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA. You will serve as a senior regulatory subject matter expert, leading complex regulatory strategies for combination products and providing technical leadership across cross-functional teams to ensure successful development and lifecycle management. #J-18808-Ljbffr Johnson & Johnson Co.
$137k - $235.75k
...Senior Principal Scientist role leading regulatory strategy and compliance for combination products at Johnson & Johnson's Innovative Medicine division... ...regulatory requirements, drug-device integration, and lifecycle... ...regulatory affairs and CMC strategy Deep knowledge...SeniorRegulatory$170k - $190k
The Senior Clinical Trial Drug Supply Manager is a critical position within the clinical development... ...execution of clinical trials and regulatory submissions. This role will be responsible... ...cohorts, randomized arms, combination therapies); Track randomization, study...SeniorRegulatoryTemporary workWork at officeFlexible hours- ...collective progress and impact.The Senior Brand Manager, North America... ...experience in medical devices, aesthetics, or life sciences... ...functional commercialization (R&D, Regulatory, Clinical) Demonstrated... ...Medical (includes Prescription Drug), Dental, Vision, Flexible Spending...SeniorRegulatoryTemporary workRemote workFlexible hours
$139.9k - $176.1k
...PTC Therapeutics seeks a Senior Scientist in Analytical Development to support method... ...to ensure analytical methods meet regulatory standards and support drug submissions. Responsibilities... ...knowledge of US and international CMC regulations, GMP, 21 CFR, and ICH guidelines...SeniorRegulatoryContract workWork at office$93.63k - $112.36k
...seeks a Formulation Scientist in Somerset, New Jersey... ...for pharmaceutical regulatory submissions, including... ...packaging materials, and device component materials. Ensure drug product and drug device combination quality and safety... ..., and Controls (CMC) activities. Perform...RegulatoryFull time$125k - $155k
...over 100 countries and regions.Senior Scientist, Product Planning and... ...an individual who seamlessly combines scientific depth with corporate... ...Discovery, Platform Development, or CMC within biopharma or top-tier... ...the next five years of drug discovery?You possess the rare...SeniorFull timeTemporary workFlexible hours$127.31k - $167.1k
...Through this strategic partnership, we combine complementary expertise and capabilities... .... Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) as part... ...decisions that may impact program strategy, regulatory submissions, project timelines, resource...SeniorRegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$109k - $174.8k
...are searching for the best talent for Senior Scientist Pharmacometrics. The Senior Scientist... ...of pharmacometrics documents related to regulatory submissions preparing responses to... ...design ofclinicalstudies and model-informed drug development plansand to support...SeniorRegulatoryFull timeLocal area- ...global pharmaceutical company is seeking a Senior Director of Clinical Safety to lead risk... ...MD and at least 6 years of experience in drug development or clinical pharmacology.... ...analyzing clinical trial data, and engaging with regulatory bodies. This position offers a pathway to...SeniorRegulatory
$210k - $215k
...We have an opportunity for a Senior Counsel to join our team. In... ...management and provide guidance on regulatory and contractual issues. This... ...law experience with a combination of large law firms and/or in-... ...your career! Join the global drug development and delivery leader...SeniorRegulatoryContract workWork at officeLocal area$128.58k - $176.8k
...by our agile, performance-focused culture.About the RoleAs a Senior Scientist, Medical & Scientific Affairs - Oral Health, you will... ...entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement...SeniorRegulatoryFull timeWork at office3 days per week- ...according to eCTD requirements for New Drug Application (NDA) Prior Approval Supplements... ...cross-functional project teams. • The Regulatory CMC Technical Associate may be called upon... ...: ContractFunction: ResearchExperience level: Mid-Senior LevelIndustry: PharmaceuticalsRegulatoryWork at officeLocal areaImmediate start
$190k - $230k
...timePosted: 2026-10-08Description:The Senior Manager, Regional Business -... ..., Operations, Medical, Regulatory, Customer Service, Finance and... ...specific background screens, drug testing and/or proof of certain... ...complex therapies, or injectables/device sales - Preferredin Experience...SeniorRegulatoryTemporary workFlexible hours- ...DescriptionThe Pharmacovigilance Scientist (PVS) will serve as a core... ..., assisting with ad hoc regulatory responses, facilitating signal... ...activities associated with new drug applications / regulatory filings... ...level: Mid-Senior LevelIndustry: PharmaceuticalsRegulatoryImmediate start
- ...the Lifecycle Management structure and strategy for parenteral drug products including SIMPONI pre-filled syringes, STELARA pre-filled... ...processes with a focus on parenteral products • Good knowledge regulatory requirements and GMP’s understands the technical aspect of the...RegulatoryContract workFor contractorsImmediate start
$113.5k - $189.3k
...Senior Environmental Project Manager There's no... ...of skilled engineers, scientists, auditors, planners and... ...Management, technical and regulatory strategy development,... ...on a hybrid model, combining in-office collaboration... ...and Fitness Tracking devices Salary Range: $...SeniorRegulatoryLive inWork at officeLocal area3 days per week- ...utilization of novel imaging biomarkers. Lead the interaction with regulatory agencies and site ethic committees for approval of clinical... ...Preferred: Minimum 5+ years of imaging experience in oncology drug development and clinical PET tracer development in a pharmaceutical...SeniorRegulatory
$113.5k
...of skilled engineers, scientists, auditors, planners and... ...is looking for a Senior Environmental Project... ...Management, technical and regulatory strategy development,... ...thrives on a hybrid model, combining in-office... ...and Fitness Tracking devices Salary Range: $113,...SeniorRegulatoryLive inWork at officeLocal area3 days per week$285.91k - $375.25k
...partnership is designed to combine the strengths and... ...Sr. Medical Director, Drug Safety & Pharmacovigilance... ...with global regulatory requirements. Core responsibilities... ...safety issues to senior management in company... ...internal safety scientist and safety operation team...SeniorRegulatoryFull timeContract workTemporary workLocal areaWorldwideFlexible hours$90k - $130k
..., biotechnology, and medical device industries. We serve some of... ...with many of the most advanced drugs, biologics, and medical... ...to join our winning team as Senior Clinical Data Managers for our... ...support to client audits and regulatory inspections. Follow up on audit...SeniorRegulatoryContract workTemporary workWork at officeRemote workWork from homeWorldwide$117k - $201.25k
...searching for the best talent for our Principal Scientist Clinical Pharmacology & Pharmacometrics... ..., and application of model-informed drug development (MIDD) principles across all... ...programs, including interactions with regulatory agencies, and serves as the CP Leader on...RegulatoryLocal areaImmediate start$38 - $43 per hour
...Description Job Description Job Title: Senior Scientist, Analytical R&D Job Description The... ...compliance with cGMP and global regulatory guidelines. The position emphasizes strong... ...and other specialized dosage forms for drug content, purity, degradation products,...SeniorRegulatoryContract workTemporary workWork at officeFlexible hoursWeekend workDay shift$155.18k - $208.37k
...Reporting to the VP & Head of Global Regulatory Affairs Pharma, the Senior Manager, Advertising, Promotion and Labeling... ...content. Partner with CMC, Safety, Medical, Quality, Clinical,... ...working knowledge of FDA prescription drug promotion requirements, OPDP and/or CBER...SeniorRegulatoryWork experience placementWork at officeRemote work$96.8k - $137k
...future for all.We are on the lookout for a dedicated Research Scientist/Sr. Research Scientist in Personal Care, based in Piscataway,... ...Understand industry/competitive trends, claim substantiation and regulatory requirements for EU cosmetic products.Project management....SeniorRegulatoryHourly payLocal areaRelocation$109.53k - $149.64k
...patients and consumers. POSITION SUMMARYThe Senior Technical Project Manager leads the end-... ..., Procurement, Manufacturing, Quality, Regulatory, R&D, Finance, Marketing, and Commercial... ...’s degree or equivalent combination of education and relevant experience required...SeniorRegulatoryRemote work- ...Senior Scientist – Adhesive Development, New Products Bridgewater, NJ Competitive Salary [about $110K] Bonus, Full Benefits, World Class Corporation SUMMARY: This position is with our Adhesive Technologies business unit Develop and optimize innovative adhesives...Senior
$89.66k - $108.64k
...it. Job Summary The Kilo Lab Scientist plays a key role in translating... ...manufacture of GMP active drug substance for pharmaceutical... ...assessment. The role requires a combination of scientific understanding,... ...working practices, quality, and regulatory compliance. Preferred...RegulatoryHourly payFull timeSummer workLive inRemote workFlexible hours$86k - $138k
The Opportunity:The Sr. Scientist is responsible for the hands-on execution of laboratory experiments and contribution to the design of... ...chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time....SeniorFull timeFor contractorsWork experience placementWork at officeLocal areaFlexible hours- ...has an exciting opportunity for someone to join our team as a Scientist in our Process Safety Lab. This position is visible and significant... ...Work closely with process and plant engineers and quality and regulatory personnel to generate material and process hazard data,...RegulatoryFull timeWork experience placement
$86k - $121k
...healthier future for all.Oral Care Research Scientist - Global Product DevelopmentThis... ...strict adherence to safety standards and regulatory guidelines.Apply a technical understanding... ...formulationsExperience running stability studies for OTC/Drug productsStrong project planning and...RegulatoryHourly payLocal areaRelocation
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