Director, Regulatory Affairs CMC

About the Role

The Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) will lead the development and execution of CMC regulatory strategy for the Company’s assets. This position will work closely with cross-functional teams, including other Regulatory functions, CMC, and Quality Assurance to ensure the successful submission of CMC dossiers and compliance with regulatory guidelines across regions throughout the product lifecycle.

Let’s talk about some of the key responsibilities of the role:

• As Regulatory CMC Lead, 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.

Factors for Success:

• Bachelor’s degree in scientific discipline required (chemistry preferred); Master’s or Ph.D. 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.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, and occasional catered meals. We provide a hybrid work environment; remote work may be considered.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our VP, Regulatory Affairs.
• Some travel may be required – up to 20%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $180,000 - $252,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.

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