- Merck & Co. (Rahway, NJ)
- …agencies and/or subsidiaries for all applications and submissions and be responsible for regulatory review and final approval for all submissions and associated ... facilitate initial approval by agencies for conduct of clinical trials.Participate in regulatory due diligence activities for licensing candidate review Minimum… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices.Collaborate effectively with IT to align system development with business and regulatory expectations. Review systems for affiliate companies to assess ... and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and … more
- Formation Bio (New York, NY)
- …collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, review and strategically contribute to ... manufacturing organizations (CDMOs) in close collaboration with Quality and Regulatory colleagues.Responsibilities: Provide analytical development technical leadership for pre-clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) ... By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure… 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)
- …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)
- …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
- 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
- Cytiva (Miami, FL)
- …and other functions, and facilitate risk-based decisions.Prepare, update and review regulatory support documentation, including Validation Guides, statements, ... about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business… more
- Aequor (Thousand Oaks, CA)
- …responsibility Knowledge and skills: Knowledge of case management and medical review SOPs and regulatory requirements for Pharmacovigilance Clinical knowledge ... Remote maximum bill rate is /hour**Job description: Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure… more
- Twist BioScience (South San Francisco, CA)
- …process quality reports by collecting, analyzing, and summarizing information and trendsWrite/ review product quality documentationFollow regulatory and ISO 13485 ... processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you will report… more
- Merck & Co. (Durham, NC)
- …for a company-Durham Facility.Completion of tasks required to release batches such as DOM/SLED Review , QN and CR review , testing review , market restrictions ... collaborative meeting groups to support release on time release group needs.Author, review , and approve local release SOPs, assist with providing product related… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.In… more
- Merck & Co. (Rahway, NJ)
- …Chemical, Automation, Safety, Technical Services, Process Development, Analytical, Regulatory , and Quality.As part of Our Company's Manufacturing Division, ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Durham, NC)
- …Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment.Develop training material. Working as a subject matter… more
- Merck & Co. (Lower Gwynedd, PA)
- …pipette calibration, maintaining records in the electronic logbook. Generate and review out-of-calibration impacts reports, share it with management and take ... company business developed through education or experience.Understands and applies regulatory / compliance requirements relative to their role.A problem solver/troubleshooter,… more
- Formation Bio (New York, NY)
- …writing strategies and operational plans.Responsibilities Leads and manages the writing, review , and finalization of clinical development documents such as protocol ... (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and ... the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide vendor comparisons and award qualified vendors.Provide SME support for regulatory inspections and regulatory filings.Author/ Review /Approve documents ... according to cGMP requirements.Support and manage change controls, draft and review SOPs and protocols, support technical investigations, and implement CAPAs to… more
