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Job #03510

About our client Our client is a world leader in the development, manufacture and distribution of generic and branded pharmaceuticals. The company has a world class management team, an excellent track record of steady growth and a robust portfolio containing some of the industry’s most reputable products. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory and Quality Manager New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all regulatory activities for company products including ANDA submissions, deficiency responses and final approval communications working closely with the FDA and international authorities 2) Manage all federal, state and formulary filings for all US business pertaining to product sale and distribution Administer complaint handling and ADE reporting for company products 3) Develop and implement overall quality review for imported products Requirements 1) 5 to 7+ years of regulatory affairs experience in the pharmaceutical industry, generics a must (successful ANDA submissions) 2) Must have previous management experience BS or better degree in scientific discipline 3) Strong working knowledge of cGMP, FDA regulations and contacts at FDA 4) Strong sense of teamwork, integrity and respect 5) Excellent verbal and written communication skills 6) Excellent organizational skills 7) Must be willing to travel occasionally