Senior Director, Regulatory Affairs CMC

POSTION SUMMARY

The Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. The position will be responsible for all CMC-related submissions: strategic planning, execution, and ensuring quality and accurate supporting documents are submitted within the agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss CMC data within cross-functional teams and with Health Authorities.

JOB FUNCTIONS/RESPONSIBILITIES

• Oversees the development and implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments, and global development programs across Mirum portfolio.
• Directly leads the regulatory CMC strategy for assigned projects.
• Responsible for ensuring the appropriate execution of all regulatory CMC strategies.
• Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
• Ensures the effectiveness of the Regulatory CMC team in developing submissions and in working across functions.
• Clearly articulates regulatory challenges/risks, identify potential solutions, leads the preparation of risk assessments on regulatory CMC topics, and effectively oversees change controls
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensures CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
• Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC.
• Supports regulatory submissions (NDA, MAA, etc.), Briefing Packages, and response documents for Health Authority interactions and address questions/requests, as well as annual updates (e.g., IB, NDA ARs, IND ARs).
• Previous experience leading CMC discussion during meetings with Health Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs.
• Effectively manages direct report(s) and provides mentorship to junior professionals.

QUALIFICATIONS

Education/Experience:

• A minimum of 12 years of relevant experience in Regulatory Affairs CMC.
• Experience in drug development focused on market applications (NDA, sNDA, MAA and variations), investigational applications (INDs, CTAs) and commercial lifecycle.
• Advanced degree in a relevant scientific discipline required, PhD in chemistry or other relevant scientific field is a plus.
• Must have experience with small molecules and biologics regulatory CMC activities, late-stage development through commercialization.
• Combination product experience/knowledge preferred.
• Demonstrated track record of successful submissions to FDA and/or other Health Authorities, including EMA. Regulatory experience/exposure to Japan and China is a plus, and other regions/countries (e.g., Canada, LATAM, MENA, Australia/NZ) is a plus.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent interpersonal, verbal and written communication skills as well as the ability to effectively partner with and influence others are essential in this collaborative work environment.
• Outstanding people management and mentorship skills are required.
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
• Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities.

Work Environment:

• This is a high-growth, fast-paced organization. The ability to be productive and a team player s critical.
• Ability to work under minimal supervision.
• Willingness and ability to travel domestically and internationally is required. It is anticipated that this will be 5-10% of work time.

The salary range for this position is $280,000 to $310,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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