Average salary: $192,356 /yearly
More statsGet new jobs by email
- ...s time for a career you can be proud of. Live What you will do Let's do this. Let's change the world. The Regulatory Affairs Manager CMC contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and...SuggestedOngoing contractLocal areaWorldwideFlexible hours
- Vanda Pharmaceuticals is seeking candidates for a role in analytical chemistry. The position involves managing analytical activities, generating and reviewing methods, and ensuring compliance with regulatory requirements. Candidates should have a Ph.D. or M.S. in analytical...Suggested
$110k - $140k
...ResponsibilitiesThe Technical Program Analyst will support SP26’s efforts related to the execution of the Common Missile Compartment (CMC) Program on board both the COLUMBIA (CLB) and United Kingdom (UK) Dreadnought (DRNT) Class Submarines.The Analyst will participate in...SuggestedContract workWork at officeFlexible hours- ...delivery, and reliability metrics.Partner with Procurement on contracting, scope definition, and cost optimization initiatives.Technical & CMC LeadershipProvide technical oversight of commercial manufacturing processes, ensuring consistent product quality and performance....SuggestedFull timeMonday to Friday
- ...synthesis and characterization of reference standards for APIs and impuritiesPreparation of analytical chemistry and stability related CMC sections of INDs, IMPDs and NDAsTrending of stability data for shelf-life prediction, Analytical comparability protocol and...SuggestedFull timeMonday to Friday
$93.6k - $156k
...software, such as JMP, for experimental design, data visualization, and interpretation.Experience with GMP manufacturingFamiliarity with CMC team functionExperience with technology transfer to manufacturingFamiliarity with chemical synthesis, protein modification,...SuggestedPermanent employmentFull timeWork experience placementH1bLocal areaVisa sponsorshipWork visaRelocation package- ...contributing to IND‑supporting studies and ethical compliance in human and animal research. Understanding of FDA regulatory frameworks, CMC and batch records, and SOP development, optimization, and documentation. Strong collaboration skills with various teams and clear,...Suggested
- ...: LinkedIn: InnoCare Pharma. Key Responsibilties Coordinate internal cross function for due diligence, including early-stage R&D, CMC, clinical, regulatory, and finance departments, providing tracking and data management support. Support projection, financial modelling...SuggestedWorldwide
- ...pivotal in providing counsel on IP matters that impact business and corporate strategy. The Executive Director will work closely with R&D, CMC, and other teams to identify and protect intellectual property, and will also be involved in IP-related transactions and due...Suggested
- ...pain neurosciences inflammation metabolic disease infection fibrosis respiratory diseases drug-discovery cmc ind enabling and drug development Business Classifications B2B Enterprise About the Role The Company is seeking...Suggested
$425k
...molecules, biologics, combination products, medical devices, and emerging technologies. Build resilient technical capabilities across CMC, manufacturing, analytical sciences, formulation, process development, external manufacturing, supply chain diversification, and...SuggestedTemporary workRemote work$79k - $90k
...Must be in good standing. URAC‑recognized certification in case management (CCM, CDMS, CRC, CRRN or COHN, COHN‑S, RN‑BC, ACM, CMAC, CMC) preferred. Travel: Must have reliable transportation and be able to travel to and attend in‑person appointments with injured workers...SuggestedFull timePart timeLocal areaHome officeFlexible hours$185k - $240k
...Description Hill International is seeking a Resident Engineer in Seattle, Washington Responsibilities Manage and direct RE staff (CMC/DBPM) in performance of tasks as described in the client's construction manual and/or other documents. Assure and document...SuggestedFull timeContract workTemporary workFor contractorsWorldwideFlexible hours$135.3k - $376.8k
...Required Knowledge, Skills, and ExperienceEducation: Bachelor’s degree in a scientific, engineering, or regulatory discipline (e.g., CMC); MS or PhD preferred.Experience: Minimum five years of experience in Regulatory Affairs related to FDA oversight of various human medical...SuggestedFull timePart timeWork experience placementImmediate startWorldwide- ...development.Proficiency in regulatory policy, process optimization, scale-up manufacturing, and chemistry, manufacturing, and controls (CMC).Experience with Total Life Cycle Cost (TLCC) management, market research, and cost estimation.Ability to prepare expert summary...SuggestedFull timeContract workTemporary workFor contractorsWork at officeFlexible hours
$165k - $215k
...Washington Responsibilities Oversee the activities of the consultant team, including the Construction Management Consultant (CMC) or Design-Build Project Management Consultant (DBPM), depending on the project delivery method. Administer the CMC/DBPM Task...Full timeContract workTemporary workFor contractorsFlexible hours- ...Lead the development and execution of strategic plans for each assigned policy area such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products. Ensure that Amgen’s regulatory policy positions are successfully represented to inform...Flexible hours
$95k - $175k
...contractual requirements and safety programs, and the contractor's approved safety plans. Procure all necessary safety equipment for CMC/DBPM staff and train all staff in proper use. Maintain records of all CMC/DBPM staff safety training. Review Contractor Safety...Full timeTemporary workFor contractorsWorldwideRelocationFlexible hours$189k - $246k
...corporate objectives. The Director partners closely with Clinical Development, Clinical Operations, Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and Executive Leadership to drive regulatory excellence throughout late-stage development. The role...Temporary workLocal areaRemote workWeekend work$150k - $195k
...requirements with the ability to work effectively in a virtual environment. This position collaborates closely with colleagues in Analytical, CMC, Quality, and Regulatory groups, supporting the corporate goals for clinical development to commercialization of a small molecule...Contract workTemporary workRemote work$57.19k - $95.31k
...period throughout the calendar year. Partners with Remote Nursing Quality Assurance Auditor to add AIS standard scores to overall CMC QSA standards and score. Partners with Remote auditor on findings to ensure opportunities for improvement are included in the plan...Work at officeLocal areaRemote workFlexible hours- ...establish regulatory systems, documentation, and processes. The candidate should be a strategic thinker, capable of influencing clinical, CMC, and organizational direction, and be comfortable in a hands-on role as the first regulatory hire. The position is suited to a...
- ...operations Support O&M transition strategy Develop reports and documentation Facilitate meetings and track actions Conduct risk and compliance tracking Experience: ~7+ years Education: Bachelor’s required Advanced degree or PMP/CMC preferred...
$183.1k - $305.2k
...product approval standards and pathways, scientific ethics and integrity, clinical trial activity, evidence development, manufacturing and CMC criteria, and biosimilars. Although US-focused, the position may also support the ex-US Public Policy & Government Affairs lead on...Temporary workLocal area- ...for FDA-regulated small-molecule drug products, providing oversight and guidance regarding regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management activities. Position Overview This position...For contractorsRemote work
$44.99k - $79.46k
...., R, Python). Translational & Regulatory Knowledge : Experience or a structural understanding of translational pipelines, including CMC compliance, Investigate New Drug (IND) related documentation, or participation in supporting clinical trial studies. Project Portfolio...Full timePart timeTraineeshipRemote workVisa sponsorshipWork visaMonday to FridayGeorge Washington University
Washington DC1 day ago$246k - $332k
...community. We are dedicated to elevating science and service for rare patients. Position Summary Travere is seeking an Executive Director, CMC Diligence to lead the CMC assessments of clinical/commercial-stage assets associated with external business development opportunities...Temporary workRemote workShift workTravere Therapeutics
Washington DC1 day ago$70 - $90 per hour
...Control systems on high voltage substations Perform on-site hands-on protective relay testing using relay test sets such as Omicron CMC 256/356 or Doble F6150. Examples of relays to be tested are SEL-311L, SEL-387, SEL-487, SEL-421, SEL-351S, GE L90, GE D60 among...Hourly payFull timeFor contractorsFor subcontractorLocal areaFlexible hoursWSP
Washington DC2 days ago- ...existing network of biologics sponsor and CRO relationships to open doors, build pipeline, and position Syner-G as a credible biologics CMC partner Collaborate with senior leadership on proposal development, pricing strategy, and scope definition for West Coast...Work at officeLocal areaRemote workFlexible hours
Syner-G
Washington DCa month ago $222.29k - $294.01k
...clinical study design by contributing to safety endpoint development and monitoring plans. Collaborate with Translational Sciences and CMC functions to understand mechanistic insights related to safety signals. Communicate key safety updates and risk assessments to...Full timeImmunome, Inc.
Washington DC26 days ago
