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Job #03078

About our client Our client is a rapidly expanding generic pharmaceutical company based in Minneapolis. They focus on the high-volume manufacturing of generic pharmaceuticals and OTC specialty products. Founded in 1977, they now have 250 employees, an 180,000 square feet facility and revenue of $120M this year alone. This is an excellent opportunity for the right person to join a stable, profitable and rapidly growing company! Position Location Regulatory Affairs Manager/Associate Minneapolis, Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the regulatory aspects of projects/products including the preparation and submission of correspondences and applications to regulatory agencies 2) Function as a direct liaison with regulatory authorities as well as facilitate the reviewing and approval process of applications 3) Lead and/or participate in Project Team meetings by providing regulatory support to ensure compliance with all FDA requirements 4) Provide product approval strategies with limited supervision from the Regulatory Affairs Program Manager 5) Manage the regulatory aspects of projects/products including major and complex applications submitted to regulatory agencies 6) Ensure that regulatory submissions are complete, properly formatted and comply with applicable regulatory requirements 7) Develop effective regulatory strategies for new products and communicate such strategies to the appropriate team leader, team members and/or supervisor (with limited supervision) 8) Interface directly with governmental regulatory personnel (including scientific reviewers, administrative staff and management) to facilitate the reviewing and approval of regulatory applications 9) Review documentation from departments outside Regulatory Affairs (with very limited supervision) 10) Provide advice about regulatory acceptability of plans for drug development, CMC, labeling, advertising/promotion through individual as well as RA Team and Interdepartmental Project Team contacts 11) Provide interpretive analyses of complex regulatory guidance documents, regulations or directives pertaining to the company's products 12) Remain current and knowledgeable regarding relevant regulations and regulatory practices as expressed through regulations, regulatory guidances, etc. Requirements 1) BS with 7 – 10 years of experience or MS/Pharm. D. with 4 – 7 years of experience or Ph. D. with 2 – 4 years of pharmaceutical regulatory-related or equivalent experience 2) Demonstrated accomplishments will be evaluated and substituted for extent of experience 3) Scientific writing experience 4) Excellent communication (written and verbal) skills 5) Superb organizational and interpersonal skills 6) Detail-oriented with good problem-solving skills 7) Ability to work independently and in a team 8) Ability to manage and prioritize multiple projects to meet established deadlines 9) Willingness to travel (minimal)