Strategic CMC Regulatory Lead - Small Molecules
Planet Pharma
Planet Pharma is seeking a Senior Manager, CMC Regulatory Affairs (Small Molecules) in the United States. The role drives global CMC regulatory strategies for development and lifecycle management of small molecule products, with emphasis on oral solids and manufacturing processes.
You will lead cross-functional teams, coordinate global submissions, and provide strategic regulatory guidance on IND through post‑approval changes, interfacing with FDA, EMA, PMDA, GCC authorities, and internal
#J-18808-Ljbffr$132k - $172k
...pursue our vision of becoming a leading biopharmaceutical company... ...Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory... ...lifecycle management activities for small molecule drug products, with primary...RegulatoryFull timeTemporary workRemote work$150k - $195k
...collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to... ...Director, Technical Operations (Small Molecule CMC) will provide technical oversight for... ...will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to...RegulatoryFull timeContract workTemporary workRemote work- ...Head of Toxicology, Small Molecules About the Company A clinical... ...responsible for establishing and leading the nonclinical safety and... .... This role requires a strategic and scientific leader with a... ...and a proven track record in regulatory authorship and agency engagement...Regulatory
- ...Vice President of Toxicology, Small Molecules About the Company... ...to clinical development and regulatory stages. This role demands a... ...responsible for scientific and strategic leadership, defining target... ...have a proven track record of leading cross-functional teams, be adept...Regulatory
$110.8k - $151k
...Neurocrine Biosciences is a leading biopharmaceutical company with... ...analytical development activities for small molecule drug substances from... ...compliance with cGMP, safety, and regulatory requirements. The position... ...with teams across CMC, Technical Operations, Quality...RegulatoryFull timeFor contractors$150k - $180k
...otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing... ...Associate Director, Global Strategic Sourcing & Procurement... ...ensure contracts reflect regulatory, compliance, and IP requirements... ...to Global Operatoins, CMC and other leaders....RegulatoryFull timeContract workWork at office$257.03k - $311.46k
...preparation, prosecution, and strategic counseling.Role... ...comprehensive IP legal support for small molecule radiotherapy programsDevelop... ...office actions on a global level.Lead cross-functional... ...efforts working closely with R&D, regulatory, commercial, and other departments...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$30 - $45 per hour
...Clinical is seeking a Research Associate, Small Molecule Formulation Development, for a direct... ...ongoing HPV research and intravitreal ocular CMC programs. Document with Precision:... ...rigorous records, and contribute to regulatory documentation. Enable Production: Assist...RegulatoryHourly payPermanent employmentContract workTemporary workLocal area- ...Planet Pharma is seeking a Senior Manager, CMC Regulatory Affairs in San Diego to lead global regulatory strategies for biologics development and lifecycle management. You will guide regulatory submissions and coordinate with cross-functional teams to align with regulatory...Regulatory
- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution... ...Quality content for clinical-stage submissions; small-molecule experience is preferred.Ability to manage...RegulatoryWork at officeFlexible hours
$258.68k - $313.46k
...working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill be... ...staff as Global Regulatory Lead and US Regional Regulatory... ...regulatory environment. Provides strategic and operational advice to the... ...key areas – Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$227.42k - $275.58k
...the global expertise and resources of a leading innovator in oncology. Our mission is... ..., organizational leadership, and strategic direction while fostering a collaborative... ...DMPK, Toxicology, Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology data are...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours- ...Finance to partner with the CFO and senior leaders. This role leads strategic and tactical planning, budgeting, performance analysis, and... ...tools, drives financial analysis for acquisitions, and ensures compliance with Board and regulatory requirements. #J-18808-LjbffrRegulatory
$132k - $172k
...collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery... ...rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for...RegulatoryFull timeTemporary workRemote workWorldwide$150k - $195k
...collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery... ...patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry...RegulatoryFull timeTemporary workRemote work$246.98k - $299.29k
...careers.bms.com/working-with-us.The GRS-CMC Director is responsible for... ...Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities... ...submissions from CMC Leads for clarity of both strategic and technical...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Description:We are seeking a Director, CMC-Drug Substance to join our growing... ...and enabling alignment with corporate strategic goals, regulatory guidance documents regarding pharmaceutical... ...therapeutics Prior experience in a small to mid-size biotech environment Regulatory...RegulatoryFull timeContract workTemporary workLocal areaMonday to FridayFlexible hoursShift work
- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology... ...role in building and leading its global regulatory... ...primary regulatory voice and strategic advisor across various functions... ...capable of influencing clinical, CMC, and organizational direction...Regulatory
$135k - $175k
...Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-... ...innovation, and growth. This role provides strategic direction and operational oversight... ...D, Systems Engineering, Design Quality, Regulatory Affairs, Manufacturing, and Product Management...RegulatoryFull timeWork at office$176.6k - $294.3k
...SUMMARY Discovery Network (DN), External Science Lead Biologics Discovery and Design supports Pfizer's broad strategic objectives which include creating a future R&D... ...to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue,...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$125k - $175k
...has raised over $650 million from leading life sciences investors and is... ...external service providers to enable strategic decision-making. Responsibilities Supports the CMC team in authoring Quality sections for global regulatory filings, answering regulatory...RegulatoryFull timeContract work$205k - $220k
...execution, interpretation, and strategic integration of... ...studies supporting peptide and small-molecule drug candidates from... ...multidisciplinary teams, including DMPK, CMC, Clinical Pharmacology, Regulatory, and external CRO... ...this role include: • Lead nonclinical in vitro and...RegulatoryLocal area$120k - $160k
...models – to ensure that every decision is strategic, focused, and produces exceptional... ...has an exciting opportunity for a Permit Lead to join our Design for Execution team located... ...approvals and clear interpretation of regulatory mandates. This role is instrumental in keeping...RegulatoryTemporary workWork experience placementMonday to FridayFlexible hours- ...the lending strategy and programs across consumer, mortgage, and commercial portfolios. The role focuses on aligning lending with regulatory standards, risk management, and delivering outstanding member experiences. The ideal candidate brings a bachelor’s degree in...Regulatory
$210k - $230k
...are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the... ...need. The PositionThe Director of Regulatory Affairs is Arrowhead’s Labeling... ...other functions to ensure that strategic business goals are met through the...Regulatory$91.62k - $111.98k
...discover what you excel at—all from Day One.Job DescriptionThe Small Business Relationship Manager NMLS is responsible for delivering... ...lending policies, credit structures, products, services, and regulatory requirements.Typically a bachelor’s degree or equivalent work experience...RegulatoryFull timeWork experience placementLocal area$185k - $300k
...role: Wells Fargo is seeking a Senior Lead Private Wealth Portfolio Manager to lead... ..., and key stakeholders to execute strategic initiatives and achieve business objectives... ...Maintain compliance with applicable regulatory, risk, and fiduciary requirements. Participate...RegulatoryFull timeWork experience placementWork at office$103k - $141k
...We are proud to be recognized with the Great Place to Work certification for the second year in a row. BKF is seeking a Strategic Pursuits Lead to support our Transportation team. The ideal candidate has a deep understanding of engineering, planning, design, environmental...Casual workWork at officeLocal areaFlexible hours$200k - $260k
...are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the... ...analytical ability, critical and strategic thinking skills and attention to... ...job alerts for “Lawyer” roles. Regulatory Affairs and Commercial Counsel...RegulatoryFull timeContract workPart timeSummer workWork at office$150k - $195k
...collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to... ...Summary:The Associate Director, Strategic Procurement is responsible for strategic... ...partner to Clinical Operations, Development, Regulatory, Medical Affairs, Finance, and other R&D...RegulatoryFull timeTemporary workWork experience placementWork at officeRemote workShift work
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