- System One (Park Ridge, NJ)
- …advantage + Expert Microbiology and Sterilization understanding + Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC + Strong ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …etc.) to ensure that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies. + Negotiate, draft, ... laws and regs. (including federal and state anti-kickback statutes, FCA, FCPA, FDA regulations, OIG guidance, PhRMA Code, Federal healthcare programs, state drug… more
- United Therapeutics (Trenton, NJ)
- …+ Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- J&J Family of Companies (Raritan, NJ)
- …group, enabling robust GxP Quality Management System of a diverse portfolio of drug and medical device health products and services. This individual serves as the ... to ensure quality of the GxP system, compliance with regulatory requirements and SOPs, and to ensure a continued...and business needs are met + Inspection leading/hosting experience ( FDA , EMA and other inspectorates) + Broad based technical… more
- Lilly (Branchburg, NJ)
- …Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly policy and procedures, and local procedures ... concepts and best practices related to MES technologies. + Strong understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- J&J Family of Companies (Titusville, NJ)
- …for the conduct of clinical trials and for the appropriate contributions to regulatory filings + Thorough knowledge of the drug development process is ... globally. Through this approach, we have become the industry leader in productivity, FDA approvals and breakthrough designations, with 13 new products since 2011 and… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, ... and supply chain related vendors and service providers. Support and participate at regulatory audits, such as state inspections, FDA audits, QA audits, etc.… more
- Astrix Technology (Monmouth County, NJ)
- …evaluation and benefit-risk assessment reports + Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA , etc.), internal SOPs, and quality ... standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + Interpret and… more