Manager, Tech DRA

Job Department: Drug Regulatory AffairsJob Category: Biotechnology and PharmaceuticalJob Description:
Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects. Competitive benefit and compensation programs reflect the Company’s high regard for its employees and enhance each person’s ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company’s uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today’s complex business challenges. We are an equal opportunity employer. M/F/D/V.Duties and Responsibilities:
Provide CMC regulatory guidance to international development projects (CMC sub teams)and for post-approval changes to U.S. marketed products.
Define CMC regulatory submission strategies and CMC documentation requirements. Review documentation for adequacy for submission(IND/CTAA, NDA/MAA, Supplements).
Construct CMC dossiers for U.S. and international regulatory submission during investigational and marketing authorization stages, and support their approval. Construct post-approval CMC Supplements to U.S. NDAs.
Liaise with FDA in written communications and manage meetings.
REQUIREMENTS
Requirements:Minimum BS/BA Chemistry or Biology, or Pharmaceutical Science.
Two years work experience in Drug Regulatory Affairs in pharmaceutical industry or regulatory agency (FDA).
Knowledge of U.S. and international CMC regulatory requirements.
Excellent verbal and written communication skills. Detail-oriented, well organized and good planning skills.
Must be willing to travel, both domestic and/or internationally up to ten percent of the time.