The Principal Consultant, Regulatory Affairs CMC will primarily be responsible for the daily management of regulatory requirements for one or more clients, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory authorities. The Principal Consultant, Regulatory Affairs Labeling Strategy is primarily responsible for the daily management of regulatory requirements for labeling strategy or labeling operations for one or more projects, designing and implementing labeling strategy, providing leadership to drive labeling consensus, and developing relationships with client subject matter experts and regulatory authorities. About Opus Regulatory: For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. |