Average salary: $195,487 /yearly
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- ...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
- Travere Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities conducted at Travere CDMOs. This role supports product development, clinical manufacturing, and lifecycle management...SuggestedRemote job
- ...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
- ...would be a plus. 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 would be a plus...SuggestedFull timePart timeTraineeshipRemote workVisa sponsorshipWork visaMonday 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$127k - $156k
...Drug Applications, and Conditional New Animal Drug Applications Expertise in some or all relevant FDA CVM technical areas, including CMC, effectiveness, target animal safety, human user safety, and labelingEvaluate and synthesize technical and regulatory information in...SuggestedWork at officeFlexible hours$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- ...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...SuggestedFlexible 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
- ...strategy across diabetes and metabolic programs. You will lead the Global Regulatory Team, integrate data from clinical, nonclinical, CMC, and safety, and drive FDA/EMA interactions for optimal filing and labeling decisions. Applicants should hold a Doctorate and have...Suggested
- ...Skills SAP BusinessObjects BI 4.x Platform Administration Platform installation, configuration, upgrades & migrations CMC, CMS, FRS, Web Intelligence & Crystal Reports AD, LDAP & SSO integration L1/L2 production support & troubleshooting...Suggested
$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...SuggestedTemporary workLocal area$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- ...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...
$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$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- ...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...
$20 - $60 per hour
...August 20, 2026 . Applicants must be available for the entire duration of the internship. Start date will be June 7, 2027 . The CMC Development organization at Moderna is looking for top talent in science and engineering to deliver on its mission to design...Remote jobPermanent employmentFull timeContract workSummer workInternshipSummer internshipWork at officeModerna
Bowie, MD3 days ago- ...through harnessing the power of advanced technologies.The Work:Accenture is seeking a Consultant to drive project execution in Digital CMC and PLM transformation work within our Supply Chain & Engineering practice for Life Sciences. We work with our pharmaceutical,...Full timeWork experience placementLive inWork at officeLocal 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
$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...Temporary workRemote workTravere Therapeutics
Washington DC2 days ago- ...link: 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...Worldwide
InnoCare Pharma
Washington DC3 days ago - ...parties involved Assisting with scheduling Depos, mediations, DMEs Getting records from Experts Preparing docs (jury fees, CMC statements, subpoenas, meet & confers) Trial doc prep (exhibits binders and trial binders) – Gabby would need to help with putting...Work at office
Fiore Legal
Washington DC9 days ago - ...reviewing and interpreting data and be able to summarize key takeaways. They will have a basic understanding and experience with the CMC drug development lifecycle, process risk assessments and Process Control Strategies. Ideally, they’ve been key members of cross-functional...Remote work
BrainChild Bio
Washington DC9 days ago $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 workTravere Therapeutics
Washington DC21 hours ago$169.22k - $253k
...guidance. Support transfer of material knowledge from discovery to development and clinical manufacturing teams. Contribute to IND CMC sections related to material characterization, form selection, and control approaches. Lead comprehensive material...Full timeTemporary workLocal areaRemote workWorldwideFlexible hoursOtsuka America Pharmaceutical Inc.
Washington DC2 days ago- ...neighborhoods, and an easy commute make this an appealing move for a Medical Speech Pathologist seeking balance. The SLP will receive competitive compensation and a full suite of health benefits. Connect with a CMC recruiter today for confidential details and next steps!Full timeSummer workLocal areaWeekend work
Clinical Management Consultants
Washington DC7 days ago - ...compliance with all regulatory requirements (cGMP) and internal policies and procedures About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support...Full time
PAREXEL
Washington DC21 hours ago
