Director/Senior Director Regulatory Affairs Putney
Putney is a rapidly growing drug company focused on generic drugs for pets. We seek an experienced Regulatory Affairs Director/Senior Director to lead the Regulatory Affairs team to deliver a full pipeline of product approvals.
The Director/Senior Director will report to the VP Product Development and will lead a team of 3-4 direct reports and a range of consultants to A-level performance. The Regulatory team will work in a highly collaborative, team based environment with Product Development, Quality and multiple manufacturing partners, to ensure that Putney?s expectation of high quality submissions are met, within aggressive timelines. The Director/Senior Director will leverage the regulatory experience of the Senior Vice President of Regulatory Policy and Counsel, who provides corporate regulatory guidance to Putney. The Director/Senior Director will build strong relationships with CVM to ensure the latest CVM requirements are included in all programs and that all question and issues that arise in projects can be resolved with certainty and speed.
The Director will be accountable for the submission of applications covering multiple dosage forms and as with all senior positions at Putney, a combination of both hands-on and leadership is required. While it would be a plus, experience with veterinary drug submissions to FDA is not absolutely required, as long as the candidate has regulatory experience with human drug applications. The ideal candidate would have at least 8 years of regulatory experience. 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.
The position is full time in Portland Maine, with some international and domestic travel required.
||Portland, ME |