Director, Regulatory Affairs CMC - Remote

Overview

The Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) will lead the development and execution of CMC regulatory strategy for the Company’s assets.

In Short

• Act as the primary interface between CMC SMEs and Regulatory Affairs.
• Develop and align global regulatory CMC strategies with product development plans.
• Assess manufacturing process changes and provide regulatory guidance.
• Manage CMC submissions and responses to Agency queries.
• Identify and mitigate regulatory risks related to CMC.
• Provide regulatory support for quality systems.
• Ensure stakeholders are informed of developments impacting regulatory success.

Requirements

• Bachelor’s degree in scientific discipline required; Master’s or Ph.D. preferred.
• Minimum of 15 years relevant regulatory experience.
• In-depth knowledge of global CMC regulatory requirements.
• Proven track record of successful CMC submissions.
• Ability to manage complex projects with strong project management skills.
• Excellent written and verbal communication skills.
• Ability to thrive in a fast-paced environment.

Benefits

• Hybrid work environment; remote work may be considered.
• Comprehensive benefits including health, dental, and vision insurance.
• Generous paid time off including vacation, holidays, and personal days.
• Opportunities for bonus and stock equity.