Job Description
Director-Regulatory Affair, qualified w/ master's or foreign equiv deg in Chemistry or Pharmaceutical Engg & 6 mos of work exp to Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance w/ regulatory stds. Dvlp regulatory strategies & implmtn plans for the prep'n & submission of new products. Leading cross functional teams across the globe incl Bus. dvlpmt, Formulation dvlpmt, Analytical dvlpmt, Regulatory affairs, Qlty assurance, Supply chain operations, Global sourcing, Finance, Intellectual property rights, Contract mfg orgs, Contract research orgs (Clinical Trials), Contract Testing Labs & representing the team during audit process of regulatory inspections such as USFDA audits. Salary $220,272.00/ annum. Aspiring candidates should mail their resumes to HR Mgr, RK PHARMA, 401 N Middletown Rd, Bldg 215/215A, Pearl River, NY 10965. Job Loc: Pearl River, NY