Director, Regulatory Affairs Strategy

Role Summary

The Director of Regulatory Affairs Strategy is responsible for executing the company’s regulatory strategy across development and commercial product portfolios. This role reports to the Senior Vice President, Regulatory Affairs and serves as the primary regulatory affairs lead for project teams, providing leadership for regulatory strategic planning and execution to achieve program milestones. The position oversees day-to-day operations of the regulatory affairs function, including management of open regulatory applications (INDs and NDAs) with emphasis on high-quality, timely submissions to regulatory agencies (primarily FDA). Submissions include INDs and NDAs (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans. The role coordinates, guides, and oversees global health authority interactions and regulatory submissions with support from partners and regional vendors.

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.
• 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).
• 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 authorities.
• 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/biotechnology, with extensive knowledge of all aspects of drug development.
• Must demonstrate recognized leadership qualities in previous roles.
• Strong project management skills are a plus.
• Strong knowledge of current US and global regulations and guidance.
• 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 teams.
• 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 priorities.