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Job #03548

About our client Our Client is a pharmaceutical manufacturer headquartered in MD with manufacturing facilities in MN. They focus on producing OTC and prescription drugs. Due to expansion, they are urgently seeking to hire a Regulatory Affairs Manager. This is an exciting opportunity for the right candidate to join a growing company Position Location Regulatory Affairs Manager Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop strategies for the filing of ANDA products and maintain compliance with currently approved NDA and ANDA products 2) Maintain up to date knowledge on current US Regulatory requirements and ICH guidelines 3) Function as the liaison between the Company and US Regulatory Agencies 4) Participate as a team member on Product Development Teams 5) Preparation of high quality submissions of ANDA’s, Annual Reports, and Supplements/Amendments 6) Perform internal evaluation of change controls and assess the impact on Regulatory filings and develop filing strategies 7) Facilitate timely Regulatory Approvals by ensuring the Quality and appropriateness of submission documents 8) Maintaining Regulatory compliance of marketed products 9) Performs other duties as assigned or requested Requirements 1) BS/MS/Pharm.D or Ph.D. in Chemistry, Biology, Biochemistry, Engineering or related Pharmaceutical field or equivalent experience 2) A minimum of 3 years of direct experience in filing ANDA’s, Annual Reports and Submissions/Amendments 3) Must posses eCTD advanced publishing skills 4) Ability to work effectively with cross-functional teams and to influence appropriate plans and actions