- ConvaTec (NJ)
- …Under Bond (TIB) process for goods entering the country for temporary purposes ensuring regulatory adherence. + Manage the FDA Import for Export (IFE) program ... and experience working in customs programs globally eg Import for Export ( FDA ), Temporary Imports, Free Trade Agreements, Preferential Origin. + Experience working… more
- Wolters Kluwer (Princeton, NJ)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Experience with state and federal health care programs, fraud and abuse laws, FDA , FTC, and the legislative and regulatory process. + Familiarity with ... Policy teams and senior management on complex policy issues, statutory and regulatory interpretation, and legal strategies to protect the Company's interests. The… 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 synthesize… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …gained through direct support of commercial manufacturing. + Extensive knowledge of FDA /EMEA cGMPs and other global regulatory compliance guidelines (eg, ICH) ... development plans and assist in the creation of strategic objectives for regulatory filings. + Provides leadership and statistical SME support for complex data… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- System One (East Windsor, NJ)
- …for creating a QA system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. + This position will also review ... all finished product batches for compliance with applicable regulatory requirements and current Good Manufacturing Practice (cGMP) standards...guidelines for creating a QA system to notify the FDA of illegitimate products, as and when needed. +… more
- Adecco US, Inc. (Ridgefield, NJ)
- …syringe products produced on site. + Maintaining compliance with all applicable Regulatory requirements relative to FDA , cGMP Regulations, Companys SOPs and ... Safety Regulations. **Requirements:** + Experience operating automated Visual Inspection and/or Packaging equipment in a cGMP manufacturing environment is preferred. + Engineering background is preferred. This role is being recruited for by one of our… more
- Adecco US, Inc. (Ridgefield, NJ)
- …functions, additional responsibilities include maintaining compliance with all applicable Regulatory requirements relative to FDA , cGMP Regulations, Companys ... SOPs and Safety Regulations, accurate documentation on batch production records and logs, and cleaning and maintain production areas. **Requirements:** + Experience operating automated Visual Inspection and/or Packaging equipment in a cGMP manufacturing… more