- Merck & Co. (North Wales, PA)
- … and label update processes and collaborate with the Medical Legal Regulatory Review teams to find solutions and make improvementsDevelop/enhance resources ... ongoing support to job owners and agency partners on promotional review processes and systems, help job owners navigate complex situations, conduct… more
- Merck & Co. (Upper Gwynedd, PA)
- …and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned ... regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.Manage execution… more
- Formation Bio (New York, NY)
- …with global regulatory expectations (eg, FDA, EMA, ICH); author and review regulatory submissions including INDs, BLAs, and other key documents. Continuous ... development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics… more
- TrackFive (Wichita, KS)
- …accordance with the Los Angeles County Fair Chance Ordinance, FlexCare conducts a review of criminal history after a conditional offer of employment has been made ... and upholding ethical standards in compliance with healthcare regulations. Additionally, the review may consider the potential impact on the nurse's ability to meet… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate,… more
- Abbott (Minneapolis, MN)
- …submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders. ... of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities. Evaluate risk… more
- Cleerly (Denver, CO)
- …States and account for geography when determining base salary. Responsibilities (General) Regulatory Submissions & Liaison: Prepare, review , and complete ... regulatory agencies (eg, FDA, Health Canada, Europe), and communicate with regulatory authorities throughout the development and review of submissions. Define… more
- Merck & Co. (South San Francisco, CA)
- …enhances data-driven decision-making. -Ensure the clarity, accuracy, and conciseness of regulatory documents to facilitate the review process. -Implement ... ability to influence scientists to adapt to positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- TrackFive (Wichita, KS)
- …arrhythmias, ensuring appropriate treatments are delivered. Participate in patient rounds to review and update care plans as necessary. Infection Control and Safety: ... Ensure patient records are in compliance with institutional and regulatory standards, including HIPAA guidelines. Document any post-procedure complications, patient… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor ... and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory… more
- Interactive Brokers (Washington, DC)
- …with IBKR's Regulatory Correspondence (RC) team to respond to routine regulatory inquiries Review , oversee, and provide legal advice regarding IBKR's ... is an exciting opportunity to join IBKR's growing Legal Department. The Regulatory Correspondence Counsel will oversee and provide legal input regarding various … more
- Merck & Co. (North Wales, PA)
- …agencies, or investigators.-10. Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.11. Participates with ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Katalyst HealthCares and Life Sciences (Chula Vista, CA)
- …the review of Traditional 510(k) Premarket Notifications. Interact with regulatory agency reviewers as well as distribution partners to facilitate product ... lifecycle. Interpret applicable standards, regulations, and directives to ensure global regulatory compliance. Review product labeling for global compliance.… more
- Merck & Co. (Rahway, NJ)
- …investigators.-Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.Participates with management in ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Katalyst HealthCares and Life Sciences (Skaneateles Falls, NY)
- …responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data ... perform other duties assigned. Track of status and progress of regulatory documentation. Review , edit and proofread regulatory documentation. ssist in… more
- Abacus Service Corporation (Princeton, NJ)
- …for eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions documents electronically to ensure all ... Regulatory requirements are met. Major Accountabilities *Support review and approval of OPDP submission documents such as Important Safety Information (ISI)… more
- Michael Page (Skokie, IL)
- …FDA (21 CFR), FSMA, DSHEA, GMP, FTC, Health Canada, EFSA, and other relevant global regulatory bodies. Labeling & Claims Review : Oversee the review and ... innovation, and integrity. Renowned for their steadfast commitment to quality, regulatory compliance, and consumer trust, they create cutting-edge products that not… more
