- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and FDA requirements with demonstrated ability to convert complex regulatory guidelines into practical, implementable solutions + Proven expertise in Quality ... + Coordinate critical product changes, assessing 360 impacts (technical, regulatory , business) and supporting customer understanding and adoption. + Prioritize… more
- Penn Medicine (Woodbury Heights, NJ)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... items in appropriate location. + CSRs, if applicable as per regulatory guidelines: Maintains medication storage closet inventory and security; checks expiration… more
- Sumitomo Pharma (Trenton, NJ)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Lilly (Branchburg, NJ)
- …and supports laboratory and/or manufacturing systems to meet business and regulatory needs. This position requires business area knowledge and computer expertise ... stay current and relevant. + Assure adherence of applicable regulatory (ie cGXP, CFR, etc.) practices during execution of...regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg Privacy, OSHA, etc.)… more
- Teva Pharmaceuticals (Edison, NJ)
- …acceptance testing and commissioning support, ensuring compliance with company and regulatory standards. + Collaborate with Engineering, Operations, Supply Chain and ... and knowledge transfer within the engineering team. + Support regulatory inspections and audits, serving as an SME for...Good Manufacturing Practices ( cGMP), Food and Drug Administration ( FDA ), OSHA and related federal, state and local laws,… more
- Norstella (Trenton, NJ)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- J&J Family of Companies (Raritan, NJ)
- …. Working with functional partner leadership (eg, Global Clinical Operations (GCO), Regulatory , Global Medical Safety) to achieve common goals + Presenting and/or ... responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations + Participating in formulating our… more
- Deloitte (Morristown, NJ)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in.../EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years… more
- AbbVie (Jersey City, NJ)
- …AbbVie's clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible ... of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and supply chain related vendors and service providers. Support and participate at regulatory audits, such as state inspections, FDA audits, QA audits, etc. ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more