Regulatory CMC Product Lead — Associate Principal Scientist
Organon Comercializadora S de RL de C.V
Organon seeks an Associate Principal Scientist to develop and implement Regulatory CMC strategies for assigned products, leading the preparation and submission of CMC dossiers for lifecycle maintenance, registrations, and post-approval changes. This role may manage a team of 1–2 contributors or outsourcing partners to support project execution. The candidate will lead global regulatory strategy, assess regulatory requirements, and ensure timely submissions while coordinating with manufacturing #J-18808-Ljbffr Organon Comercializadora S de RL de C.V
- ...Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is responsible for... ...small molecule or biological products in accordance with global regulations... ...Principal Scientist will lead the preparation and...PrincipalRegulatory
- Organon LLC is seeking an Associate Principal Scientist to develop and implement Regulatory CMC strategies for small molecule or biologics, leading CMC dossiers for lifecycle changes and registrations... ...conformance, and drive timely product supply while collaborating with...PrincipalRegulatory
- Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for assigned products in the United States. The role involves preparing and reviewing information... ...regulatory conformance. The candidate will lead CMC submission components, assess risks, and...Regulatory
- ...Position The Senior Scientist is responsible for implementing Regulatory Chemistry,... ...Manufacturing & Controls (CMC) strategies for... ...molecule or biological products in accordance with... ...strategies by leading the development, authoring... ..., including associated vaccination...RegulatoryWork experience placementRelocationVisa sponsorshipRelocation packageFlexible hours
$55 - $68 per hour
Principal Scientist, NA Skin Health & Consumer Science Kelly Science and Clinicalhas... ...one of our Global consumer product & pharmaceutical clients in... ...role is responsible for leading and executing consumer... ...company procedures and regulatory requirements. Qualifications...PrincipalRegulatoryWork experience placement- Shionogi Inc. is seeking a Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned... ...with a risk-based approach. Responsibilities include leading global CMC strategies, coordinating timelines, liaising...Regulatory
- Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director. You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans...Regulatory
- ...extension possibility) Summary: The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the... ...background packages (including participating / leading HA meetings with support); and/or post-...RegulatoryFull time
- Job-ID29499131Reference26-29348Scientific - Global Regulatory CMC Manager EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”Regulatory
$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor... ...authorities. Responsibilities Lead development of Global CMC regulatory strategies across the product lifecycle. Define, prioritize, and execute...RegulatoryFull timeWork at officeLocal area$93.6k - $140.4k
...Research Scientist Formulation DevelopmentAt Bayer we're visionaries, driven to solve the... ...create new over-the-counter consumer health products. In this role, you'll work in the lab... ...-functional teams including analytical, regulatory, technical, and commercialIdentify technical...Regulatory$140k - $170k
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the... ...the success of Shionogi’s pipeline products and initiatives. Responsibilities Collaborate... ...additional compensation that may be associated with this role. EEO Shionogi Inc. is...RegulatoryFull timeLocal areaWork from home2 days per week3 days per week$93.6k - $140.4k
...difference, there’s only one choice.Research Scientist Formulation DevelopmentFormulation... ...create new over-the-counter consumer health products. In this role, you’ll work in the lab... ...-functional teams including analytical, regulatory, technical, and commercialIdentify technical...RegulatoryLocal area- Sanofi is seeking a Real World Evidence Scientific Lead in Morristown, NJ (with Cambridge, MA) to drive end-to-end RWE strategies for... ...with global teams, and ensure high scientific quality for regulatory and market access uses. The ideal candidate holds an advanced degree...Regulatory
- ...commitments and ensuring compliance with global regulatory requirements. Position Summary /... ...Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams.... ...Teams and participate in related PV and product-development subteam(s). Appropriately elevate...RegulatoryWorldwide
- ...labor as a variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory... ...strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure...RegulatoryImmediate start
- ...reporting gaps. Prepare M&A analysis, budgets, forecasts, and monthly reports. Ensure SOX compliance. Research legislative and regulatory developments and collaborate with Legal to establish appropriate procedures and best practices. Identify opportunities to...RegulatoryInternshipLocal area
- ...Squibb Co in Madison, NJ is seeking a pharmacovigilance professional to lead signal detection and safety assessment across the product life cycle. You will prepare safety sections for regulatory documents and support postmarketing safety activities. Ideal candidates have...Regulatory
$86.8k - $100k
...Historic Preservation Act. Dewberry is a leading, market-facing professional services... ...senior cultural resource staff. Serving as Principal Investigator for architectural resource... ...of geographic locations under a range of regulatory contexts. Document historic properties in...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$40.79 - $52.03 per hour
...analyze and verify test results, adhere to quality assurance and regulatory standards, and collaborate with physicians, nurses, and other... ...responsibility for actively contributing to the section's productivity and cost-effectiveness, Assumes responsibility for...RegulatoryHourly payFull timeTemporary workWork at officeFlexible hoursShift workAfternoon shift- ...clinical trial teams to support early or late stage clinical programs. Contribute expert input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPD's and...RegulatoryImmediate start
$110k - $160k
...training of junior staff; conducting preliminary research, provide regulatory consultations, perform project specific field studies and... ...experience; Certified Ecologist and/or Professional Wetlands Scientist (PWS) certifications required; Must have strong knowledge...RegulatoryFull timeTemporary workFor contractorsWork at officeRemote workFlexible hours$40.79 - $52.03 per hour
...operate and maintain sophisticated laboratory instrumentation, analyze and verify test results, adhere to quality assurance and regulatory standards, and collaborate with physicians, nurses, and other healthcare professionals to deliver exceptional patient care. Joining...RegulatoryHourly payPart timeShift workNight shift- ...use of medicines and proactively communicate safety evidence. You will independently perform core signal detection activities, lead SDRMs, and ensure pharmacovigilance regulatory compliance across development and marketed products. #J-18808-Ljbffr Bristol-Myers Squibb CoRegulatory
$153.94k - $199.21k
...Working in collaboration with the Clinical Scientist Program Lead, you are accountable for various... ...analysis/reporting and support of regulatory filings. EXAMPLE RESPONSIBILITIES Acquires... ...development phases and the nature of associated clinical trials across phases....RegulatoryWork at officeLocal areaFlexible hours- ...groundbreaking technologies, in-depth regulatory know-how, manufacturing and process... ...(Switzerland), Arxada employs 3,100 associates across 24 production sites and 14 R&D centers, all... ...opportunity for a collaborative, hands‑on scientist who thrives in a dynamic laboratory...RegulatoryTemporary workWork at office
- ...General Supervisor, the Medical Laboratory Scientist processes specimens, performs high/... ...accurate results. Ensures compliance with regulatory standards, maintaining quality control,... ..., physical or biological, OR Associate degree in chemical, physical or biological...RegulatoryDaily paidWork experience placementShift work
- ...Care Supervisor, the Medical Laboratory Scientist processes specimens, performs high/... ...accurate results. Ensures compliance with regulatory standards, maintaining quality control,... ...patient care and workflow efficiency. Principal Accountabilities: Specimen Processing and...RegulatoryFull timeShift work
$119.7k - $222.3k
...Join to apply for the Principal Biostatistician role at Novartis... ...Provide statistical support for regulatory submissions including... .... -Responsible for advising/leading the planning, development &... ...With our people. It is our associates that drive us each day to reach...PrincipalRegulatoryFull timeContract workRemote workRelocation package- Position Title: Senior Scientist, Data Science and Reporting, CPV - GMSAT Work Location:... ...Process Verification) and APQR (Annual Product Quality Review) reporting. The incumbent... ...includes supporting the APQR, as required by regulatory agencies. The incumbent will monitor/...RegulatoryWork experience placement
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory CMC Product Lead — Associate Principal Scientist. Be the first to apply!
- machine learning scientist Florham Park, NJ
- health scientist Florham Park, NJ
- quality control scientist Florham Park, NJ
- scientist Florham Park, NJ
- scientist biology Florham Park, NJ
- manufacturing scientist Florham Park, NJ
- research scientist - biology Florham Park, NJ
- scientist immunology Florham Park, NJ
- qc scientist Florham Park, NJ
- deep learning scientist Florham Park, NJ





