- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Organon & Co. (Jersey City, NJ)
- …Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned ... the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed **Required Education,… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and post-approval/ ... Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved… more
- Merck (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Pharmaceutical Development, Pharmaceutical Microbiology, Pharmaceutical Sciences, Pharmacokinetics, Product Development, Regulatory CMC , Software Development {+ 3 more}… more
- Bayer (Whippany, NJ)
- …+ Deep understanding of Pharmaceutical R&D business processes (preclinical, Clinical, CMC , Regulatory , PV) and underlying data, procedures, policies and ... to make a real difference, there's only one choice.** ** Director R&D Reg Data Mgmt Expert DSAI** **YOUR TASKS...management with an initial specific focus on product and regulatory data. This role has broad accountabilities for the… more
- Bayer (Whippany, NJ)
- …clinicians, clinical operations, bioanalysis, biomarker specialists, pharmacometrics, pharmacovigilance, regulatory affairs, statistics, and PS ( CMC ) groups. ... clinical operations, data management, pharmacometrics, medical writing statistics), pharmacovigilance, PS ( CMC ), regulatory affairs to best use CP concepts… more
- BeOne Medicines (Pennington, NJ)
- …and process troubleshooting. This position involves close collaboration with the CMC , Process Development, Manufacturing, Quality Control, Quality Assurance and ... Regulatory groups. This position requires advanced technical expertise in...of the role. + Broad knowledge of drug development, CMC , MST, preclinical and clinical requirements. + Experience in… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than… more
- Merck (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Bristol Myers Squibb (Summit, NJ)
- …strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product ... but not limited to, continued process verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class… more