- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on ... identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders Job Summary: The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory ... commercial goals. This role also involves managing a team of regulatory professionals, fostering collaboration across departments, and maintaining a proactive… more
- Merck & Co. (North Wales, PA)
- …Legal Case Management, Legal Research, Legal Strategies, Negotiation, Pharmaceutical Law , Regulation Enforcement, Regulatory Compliance, Team Play-Preferred ... and support for US litigation matters and data subject requests.Support global regulatory scanning efforts and, with respect to the US, evaluate potential changes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional,… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: ... execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have advanced experience working on Phase ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… 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
- Insmed Incorporated (San Diego, CA)
- …Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & ... CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP) and company SOPsPerform user acceptance… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy ... maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...veteran status, age, or any other characteristic protected by law . Salary Range: $230,175.00 - $383,625.00[Link available when viewing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... the prompt identification of safety signals.Lead internal and external (especially regulatory , but also expert advisory) interactions to ensure quality outcomes in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy ... continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …order to manage/process patent term extensions, Orange Book listings, claims for regulatory exclusivity, as well as ensure that any new patent protections available ... etc.; counsels development teams for pipeline products on IP, regulatory , and contractual issues arising during the course of...Degree In Chemistry or Biology sciences required- JD from Law School of recognized standing, and Bar Admission in… more
- Lundbeck (Bothell, WA)
- …capacity, manage outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize ... Author and review cell line development technical reports that meet expectations of regulatory agencies for all stages from IND to BLA. Present updates at… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in ... network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive experience… more
- BioAgilytix (Durham, NC)
- …ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy ... vendor and third-party security risk, ensuring adherence to contractual and regulatory obligations.Define guardrails for AI and new technologies, including M365… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has ... of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute the strategy ... global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing procurement management to optimize the vendor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory… more
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