Senior Director, Regulatory Affairs (Office or Remote)

Senior Director Of Regulatory Affairs

The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally. Acts as a resource to the broader regulatory function, including mentorship of less experienced staff.

Note : Regulatory Group works Pacific Time Zone hours.

Responsibilities :

• Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success
• Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets
• Represents the regulatory function on cross-functional development teams
• Plans, prepares, and reviews submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications
• Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives
• Serves as the primary point of contact with FDA and other health authorities as applicable
• Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction
• Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects
• Manage and provide guidance / training for regulatory staff members, including regular feedback and coaching for professional development
• Develop relationships with external partners
• Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs
• Provides regulatory guidance and / or training to external departments
• Prepares and revises internal procedures for continuous improvement
• Manages activities performed by regulatory

Education / Experience / Skills :