Director, Regulatory Affairs CMC

Summary

Join Tarsus Pharmaceuticals as the Director, Regulatory Affairs CMC and lead the development and execution of CMC regulatory strategy for the company's assets. You will collaborate with cross-functional teams to ensure successful CMC dossier submissions and regulatory compliance. Key responsibilities include acting as the primary interface between CMC SMEs and Regulatory Affairs, developing global regulatory CMC strategies, assessing manufacturing process changes, and managing CMC submissions. The ideal candidate will possess a Bachelor's degree in a scientific discipline (chemistry preferred), 15+ years of relevant regulatory experience (8+ years in regulatory affairs CMC), and in-depth knowledge of global CMC regulatory requirements. The position offers a hybrid work environment, competitive base pay ($180,000-$252,000), bonus, stock equity, and comprehensive benefits including health, dental, vision insurance, and generous paid time off. The role is based in Irvine, CA, with up to 20% travel.

Requirements

• Bachelor’s degree in scientific discipline required (chemistry preferred)
• Minimum of 15 years relevant regulatory experience, with 8 years of industry experience in regulatory affairs CMC
• Experience with small and large molecules is required and ophthalmic products is highly desirable
• In-depth knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH, etc.)
• Considerable experience with CMC development, process validation, comparability protocols, amendments, and supplements
• Proven track record of successful CMC submissions for INDs, NDAs/BLAs, and other regulatory filings
• Experience with producing CMC dossier sections from early development to pre- and post-approval submissions (e.g., INDs/NDAs/MAAs/ Annual Reports/IMPDs) and familiarity with eCTD structure and granularity requirements
• Ability to manage complex projects with independent decision-making and analytical thinking skills; strong project management skills
• Excellent written and verbal communication skills. Ability to effectively communicate complex technical information to regulatory authorities, senior management, and cross-functional teams
• Ability to thrive in a fast-paced, dynamic environment and manage changing priorities

Responsibilities

• Act as the primary interface between CMC subject matter experts (SMEs) and Regulatory Affairs
• Develop and align global regulatory CMC strategies with overall product development plans and company goals, through collaboration with project teams, CMC, Quality, and other regulatory strategists
• Assess proposed manufacturing process changes and provide strategic regulatory guidance for global implementation
• Independently plan, execute, and manage CMC submissions and responses to CMC-related Agency queries for assigned projects in various phases of clinical development, global marketing applications, and post-approval activities
• Identify and mitigate potential regulatory risks related to CMC and ensure CMC activities comply with relevant regulatory guidelines (FDA, EMA, ICH, etc.)
• Provide regulatory support for quality systems such as change control and inspection management. Support interactions with regulatory agencies during inspections
• Ensure project team colleagues, line management, and key stakeholders are informed of developments that may impact regulatory success

Preferred Qualifications

Master’s or Ph.D. preferred

Benefits

• Hybrid work environment; remote work may be considered
• Expected base pay range for this position is $180,000 - $252,000 plus bonus, stock equity, and comprehensive benefits
• Health, dental and vision insurance benefits
• Generous paid time off, including vacation, holidays, and personal days