Senior Director, Regulatory Affairs - Remote

Overview

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.

In Short

• Provides strong regulatory and scientific leadership to the overall development team.
• Interprets and applies regulations for US and international markets.
• Represents the regulatory function on cross-functional development teams.
• Plans and reviews submissions to regulatory authorities including FDA and EMA.
• Works with regulatory submissions coordinator on submission timelines.
• Serves as the primary point of contact with FDA and other health authorities.
• Interacts with regulatory agencies and maintains correspondence.
• Manages maintenance plans for regulatory applications.
• Provides guidance/training for regulatory staff members.
• Monitors and disseminates intelligence on regulatory matters.

Requirements

• Bachelor’s degree in a life science required, PhD or Master's preferred.
• 8+ years in regulatory affairs with 12+ years in biotech/pharma.
• Experience in oncology drug development is a must.
• Thorough knowledge of US and international regulations.
• Experience managing development of INDs and global clinical trial applications.
• Excellent verbal and written communication skills.
• Demonstrated problem solving and conflict resolution skills.
• Proficiency in MS Office applications.
• Skilled at negotiating with business partners.
• Proficient at creating and communicating a clear vision.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.
• Equal Opportunity Employer.