- 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
- 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)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for...qualifications below with or without a reasonable accommodation. Education:Bachelor's Degree Nursing, Pharmacy, Life Sciences, Health Care or related… 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
- Twist BioScience (South San Francisco, CA)
- …of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation: Oversee the full Software… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet ... accommodation.Education Qualifications (from an accredited college or university) Bachelor's Degree in a scientific, healthcare or related discipline required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews ... implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA information in the eQMS in… 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
- Insmed Incorporated (San Diego, CA)
- …including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert knowledge of scale-up principles with respect to viral ... procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions.Must be familiar with BSL-II lab safety requirements.Participate...of 8 years of related experience with a Bachelor's degree ; or 6 years and a Master's degree… more
- Merck & Co. (Rahway, NJ)
- …you interested in the intersection of scientific innovation and property law , especially how to efficiently capture innovation with intellectual property, ... of the business including discovery, development, manufacturing and supply, regulatory , business development, commercial groups, and other legal functions.Responsibilities… more
- BioAgilytix (San Diego, CA)
- …ResponsibilitiesOther duties as neededMinimum Preferred Qualifications: Education/ExperienceBachelor's degree in chemistry, biochemistry, biotechnology, or related ... twelve (12) years' experience in a scientific laboratory environment; orMaster's degree in chemistry, biochemistry, biotechnology, or related field with not less… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the training of Manufacturing ... with all levels within the organization.RequirementsA minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced… more
- BioAgilytix (Durham, NC)
- …as neededMinimum Preferred Qualifications - Education/Experience (Scientist III):Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or ... than 12 years' experience in a scientific laboratory environment; orMaster's degree in molecular biology, biochemistry, immunology, biotechnology, or related field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... reasonable accommodation.Education Qualifications (from an accredited college or university):Master's Degree or equivalent preferred orPharmD or equivalent preferred orPhD… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …MSLs.Fully understand and apply MSL SOP's/guidelines and company HCC/ Regulatory /Legal guidelines.Requirements2-3 years relevant MSL work experience in therapeutic ... disease areas consistent with Legend assets and research interests. Advanced terminal degree (PharmD, PhD, MD, DO) or other advanced medical degree (NP, PA,… more
- Twist BioScience (South San Francisco, CA)
- …HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelinesPartner with ... core values: Grit, Impact, Service, and TrustWhat You'll Bring to the TeamBachelor's degree Human Resources Management, or a related field plus 10+ years of… more
- Lundbeck (Waco, TX)
- …Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies ... and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years...protected veteran status, and any other characteristic protected by law , rule, or regulation. Lundbeck participates in E-Verify .… more
