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About our client
Our client is an international pharmaceutical company headquartered in New Jersey with a 60-year history of service in the development and commercialization of various oncology and CNS therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Position	Location
Manager of Regulatory Affairs	New Jersey
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Provide recommendations/advice to staff on regulatory aspects of development and registration of drug products 2) Prepare/submit IND applications 3) Provide leadership to regulatory affairs and administrative staff 4) Construct/submit updates to INDs, investigator brochures, annual reports and brief books for FDA meetings 5) Participate in building the regulatory infrastructure such as SOPs, forms, documentation methods and optimal methods of interacting with various departments 6) Assist in planning and preparing NDAs and ANDAs 7) Provide training and QC on project documents written by company staff
Requirements
1) Experience in preparation and submission of IND applications, NDA and ANDAs 2) Track record of success in providing operational leadership/coordination of day-to-day regulatory affairs activities 3) Strong scientific judgement 4) Exceptional communication skills