Director, Regulatory Affairs Strategy

Responsibilities:

• Executes the defined regulatory strategy across the product portfolio.
• Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.
• Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical, Quality and Operations teams, as appropriate.
• Provides guidance to teams and peers to solve problems, achieve goals and meet company defined timelines.
• Provides clear communications of regulatory risk(s) associated with development activities.
• Provides regulatory guidance and recommendations in support of company goals.
• Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate to
• Serves as primary point of contact with FDA project manager for assigned projects.
• With minimal supervision, leads the preparation of responses to Health Authorities (US and Global).
• Liaises and orchestrates meetings with cross functional
• Participates in product team meetings (development and marketed products).
• Ensures product team activities align with defined regulatory strategy
• Reviews technical documents for submission in new INDs, NDAs and provides guidance to the technical development
• Authors and prepares original INDs/NDAs and amendments for submission to Regulatory
• Manages day-to-day regulatory activities for assigned projects.
• Prepares both major and routine submissions to regulatory applications.

Qualifications:

• Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus
• Global regulatory experience in ICH regions and Canada is a plus.
• 10 to 15 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development
• Must demonstrate recognized leadership qualities in previous roles.
• Strong project management skills is a plus.
• Strong knowledge of current US and global regulations/guidelines
• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team
• Proven ability to communicate with executive management and external thought leaders.
• Demonstrated identification of key regulatory risks.
• Must be well organized, detail-oriented, and can multi-task and manage changing priority