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Sr Specialist, Regulatory Affairs CMC Job Location: Rahway NJ 07065 Onsite Requirements: CMC experience or R & D experience preparing the reports that feed into the CMC section (a quality background could be transferrable) Experience authoring technical reports and regulatory submissions, experience reviewing scientific information, with sound judgement and attention to detail Demonstrated understanding of cross functional relationships across the business (manufacturing, packaging, QC & QA as well Job Description: MAJOR ACTIVITIES AND RESPONSIBILITIES: Work independently and effectively with other functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations Review active substance master files, CEP dossiers and all supporting technical documents for suitability for use in regulatory...