- Insmed Incorporated (San Diego, CA)
- …SAE reports, etc.)Qualifications:Bachelor's degree in scientific field. Advanced degree in a scientific or regulatory area (Master's/PhD/PharmD) preferred. ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… 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
- 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)
- …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
- 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
- CoxHealth (Lake Spring, MO)
- …agreement terms and conditions. This position will also assist the Regulatory Affairs department with annual contract evaluations. The Contracted Services ... Services Director. * Job Requirements ◦ Education ▪ Required: Associate or related Degree in business or Bachelor's degree in business, accounting, economics,… 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 ... results, etc.; counsels development teams for pipeline products on IP, regulatory , and contractual issues arising during the course of product development.-… 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
- Capital One Bank (Baltimore, MD)
- …and potential implications to the firm.Stay current on the changing regulatory environment and understand the impacts to our international expansion efforts.Assist ... oversight of third party resources.Support interactions with Internal Audit and Regulatory agencies related to our work, as applicable.Participate in and execute… more
- Capital One Bank (Newport News, VA)
- …reporting on international risk topics to managementStay current on the changing regulatory environment and understand the impacts to our effortsAssist with project ... cross-functional teams through various initiativesSupport interactions with Internal Audit and Regulatory agencies related to our work, as applicableWrite and revise… 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 ... Ability to interact with all levels within the organization.RequirementsBachelor's degree in Engineering, Life Sciences, or related field (required).Advanced … 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
- BioAgilytix (Durham, NC)
- …as neededMinimum Preferred Qualifications - Education/Experience (Scientist I):Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or ... six (6) years' experience in a scientific laboratory environment; orMaster's degree in molecular biology, biochemistry, immunology, biotechnology, or related field… more
- vaco (Stamford, CT)
- …demands deep expertise in securitization, true lending practices, capital markets, and regulatory financial reporting. The CFO will play a pivotal role in optimizing ... and compliant financial reporting in accordance with US GAAP and regulatory requirements; oversee audit and tax processes.Risk Management: Develop and maintain… more
