Director Regulatory Affairs Putney
THIS JOB HAS EXPIRED Description
Putney is seeking an experienced Regulatory Affairs professional to join our rapidly growing team. The ideal candidate will have 5-8 years of experience filing ANDAs with FDA?s Office of Generic Drugs, but candidates with experience with CMC sections for NDAs, NADAs or ANADAs are urged to apply.
Putney is a rapidly growing generic drug company with a unique business strategy focused on generic drugs for pets, and the largest pipeline in animal health. No experience with veterinary drug submissions is needed as long as the candidate has experience with human drug applications, and training in an exciting, team based environment, is provided. The Director will be responsible for the compilation and submission to CVM of generic drug applications and for management of Regulatory professionals on the team. The Director will work closely with Product Development, human generic drug manufacturing partners and FDA to ensure regulatory requirements as well as Putney standards for quality and risk management are met. In conjunction with the Vice President of Regulatory and Counsel, to whom the position will report, the Director will develop product-specific regulatory strategies, focusing on high quality submissions and meeting timelines. This is an exciting opportunity to join a highly successful team and play a key role in a company at the forefront of developing and bringing to market generics for veterinarians and pet owners.
Some international and domestic travel required.
||Portland, ME |
THIS JOB HAS EXPIRED