Associate Director, CMC Global Regulatory Affairs

Job Summary

The Associate Director, Regulatory Affairs – CMC is responsible for preparing, and managing regulatory CMC submissions to support clinical development, registration, and lifecycle management for assigned project including small molecules, inhaled therapies, and drug-device combinations. This position provides regulatory guidance to internal teams, supports agency interactions, and ensures high-quality CMC documentation aligned with global standards. This role collaborates with Manufacturing, Quality, CMC, technical personnel, and external partners to ensure that CMC development and manufacturing activities align with global regulatory expectations.

If supporting YUTREPIA, this position is hybrid with at least 2-3 days a week in the office in the Research Triangle Park, North Carolina.

• Contributes to the global CMC regulatory strategies(drug and device) for assigned programs across clinical phases and commercialization.
• Prepares and reviews high-quality Module 2 and Module 3 documentation for INDs, CTAs, BLAs, MAAs, and lifecycle submissions. Includes IMPDs, annual reports, and post-approval changes.
• Support responses to health authority questions, specific advice, and regulatory intelligence monitoring.
• Manages submission timelines, document collection, and content QC.
• Maintain regulatory tracking systems, commitments, and submission archives.
• Monitor changes in CMC regulatory guidelines and communicate impacts to internal teams.

• Collaborate with Manufacturing, CMC, Quality, technical team members, partners, and vendors to align development and post-marketing activities with global regulatory requirements for filings and maintenance.
• Provide regulatory guidance on process development, analytical method validation, control strategy, manufacturing changes and supply chain activities.
• Support agency interactions as requested.
• Support risk assessments and mitigation strategies for global CMC and device regulatory matters for assigned programs.
• Prepare responses to regulatory authority information requests during the review process to support application approval and maintenance.

• Bachelor’s degree in life sciences, chemistry, biochemistry, engineering, or related field. Advanced degree preferred. RAC or similar certification a plus.
• Approximately 8years of CMC regulatory or related experience in the pharmaceutical industry with CMC regulatory leadership in biotech or pharmaceuticals.
• Experience participating in CMC content development for submissions, including original INDs/NDAs/MAAs, supplements, and global clinical trial applications for drug and drug-device combinations and responding to agency information requests.
• Developing knowledge of drug development and life cycle management concepts and interdependencies with the overall development process.

• Strong working knowledge of global CMC regulatory requirements, ICH guidelines, technical development considerations, and documentation standards.
• Excellent attention to detail, writing skills, and project coordination abilities.
• Ability to manage multiple tasks and competing priorities in a fast-paced environment.
• Ability to collaborate effectively with technical and quality-focused team members.
• Demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving with an exemplary history as a “self-starter”.
• Unrelenting dedication to support business objectives and delivering high quality results.

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia.

No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.