- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … 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)
- …electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Repligen (Waltham, MA)
- …as it pertains to IP, R&D, and business development.o Monitor legal and regulatory developments in IP law relevant to biotechnology and life ... deal structures with regard to IP ownership, licensing, and regulatory compliance. Commercial Contracts:o Draft and negotiate commercial contracts,...sciences.Qualifications JD from an accredited US law school and active license to practice in at… more
- Repligen (Waltham, MA)
- …seeking a highly motivated and detail-oriented In-House Counsel with expertise in employment law and commercial contracts. This role is ideal for an attorney with 6+ ... and disputes, while also handling a wide range of commercial agreements.ResponsibilitiesEmployment Law & Compliance Advise HR and management on employment law … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and ... Regulatory Inspection (FDA/EMS/ PMDA etc.)Guide/advice RD, PV, MA business...sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law… 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
- Merck & Co. (Rahway, NJ)
- …Government Agencies, International Economics, International Trade Finance, International Trade Law , Investigative Skills, IS Audit, Legal Regulatory Compliance, ... scientists, our Manufacturing Division and Animal Health product experts, global regulatory , controlled substances and others to enable the correct classification of… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and direct qualification activities to meet company goals, quality, and regulatory objectives. Qualification team will consist of managing external resources and ... vendor comparisons and award qualified vendors.Provide SME support for regulatory inspections and regulatory filings.Author/Review/Approve documents for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions. Contributes to CDx ... and manages multiple Companion Diagnostics Partnerships to develop, implement and gain regulatory approvals for CDx assays. May function as the main point of… 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
- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Documentations, Ethical Compliance, International Trade Finance, International Trade Law , Investigative Skills, IS Audit, Legal Regulatory ... Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation ... TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational execution and excellence by applying best practices in accordance with regulatory requirements and guidelines worldwide, and in alignment with the CSPV ... are incorporated into comprehensive safety reports as required by all regulatory authorities.Ensure a robust risk management process with appropriate tools, serving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for all key health ... Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory AffairsLeadership/ team management:Create a high performing team environment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as Subject ... Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).Responsible to maintain permanent inspection readiness and… more
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