Job Information
Cosette Pharmaceuitcals Sr. Director, Regulatory Affairs in South Plainfield, New Jersey
Lead and formulate regulatory affairs strategy for pharmaceutical products and analyze FDA regulatory requirements for all pharmaceutical dosage forms, applying Analytical method development and validation, USP/NF, 21 CFRs FDA guidelines; Plan, prepare for, and manage all regulatory submissions, including CTD/eCTD (Electronic Common Technical Documents), NDA, and ANDA; Perform regulatory risk assessment and provide regulatory input to the CEO and executive team; Provide regulatory strategy for new pharmaceutical developments; Review and approve SOPs to regulatory authorities; Optimize and implement new processes in drug R&D and applications; Research and keep up-to-date on latest regulatory requirements and regulatory changes; Review and approve documents related to pharmaceutical product development, manufacturing, and testing; Train, develop, and mentor new and current members of the regulatory team; Supervise 3 regulatory affairs specialists. Must have a Master’s Degree in Pharmaceutical Chemistry, Pharmaceutical Science, or Regulatory Affairs plus 2 years experience in job offered or as Director, Regulatory Affairs. Require skills and knowledge of ANDA/NDA, Analytical method development and validation, USP/NF, 21 CFRs FDA guidelines, CTD/eCTD. Submit résumé referencing job code REC002 to HR, Cosette Pharmaceuticals, Inc., 101 Coolidge Street, South Plainfield, NJ 07080.
