- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Merck (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Ascendis Pharma (Princeton, NJ)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- Actalent (Branchburg, NJ)
- …safety of donated human tissue. This role involves maintaining compliance with FDA , AATB, international, and state regulations during the second level quality review ... donor suitability and distributed products, triggering escalation procedures and evaluation for regulatory action. Essential Skills + 5 years of experience as a… more
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... applicable regulatory agencies. Expectations are to be familiar with and...interpersonal skills. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred. + Knowledgeable in Microsoft… 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
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... applicable regulatory agencies. Expectations are to be familiar with and...interpersonal skills. * Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred. * Knowledgeable in Microsoft… more
- Kedplasma (Cinnaminson, NJ)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and...collection center for audits. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. +… more
- Terumo Medical Corporation (Somerset, NJ)
- …with medical, regulatory and legal partners to assure compliance with FDA regulations US laws and appropriate clinical representation of assets. + Administer ... new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned employees are aware… more