Seattle area Biotech company focused on development of oncology therapeutics is seeking candidates for a Senior Manager opening within the Regulatory Affairs department.  This is an exciting opportunity with a local R&D leader currently in the midst of an NDA and with the expectation to file another NDA within the next year.

Description:

Reporting to the VP Global Regulatory Affairs, the position will focus on supporting the development and implementation of Regulatory strategies for post-marketing activities on commercial projects. 

Responsibilities will include, but not limited to:  develop and implement strategies in coordination with project team members to facilitate product and regulatory approvals.  Develop best practices, working instructions, SOPs for product promotion and compliance activities.  Provide leadership in development and review of materials pertaining to prescription drug promotion and advertising.  Manage submission of regulatory documentation/correspondence and applications on Marketing, Advertising and Communication to FDA (DDMAC) as well as supporting submissions for Europe, South American and Canada in accordance with marketing timelines and regulatory guidelines.  Will act as a direct interface to regulatory authorities and manage/lead action on responses by the FDA, other regulatory agencies, or Health Authorities.  Will collaborate with Project Teams for the review and approval of promotional programs and materials against Regulatory requirements for marketed products to facilitate the prompt review and approval of applications for assigned products.

Requirements: