Associate Director, Regulatory CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the development and implementation of CMC regulatory strategies for investigational and commercial small molecule and ASO programs under the guidance of the Senior Director.

• Write, compile, and review CMC sections of regulatory submissions, which include INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements.

• Facilitate the development of CMC content in collaboration with Quality, Analytical, Development, and Commercial Manufacturing teams.

• Aid in interactions with health authorities, including the preparation of briefing documents and responses to information requests.

• Ensure regulatory compliance for CMC activities that support clinical and commercial supply.

• Provide assistance with post-approval change management, comparability assessments, manufacturing changes, and technology transfers.

• Oversee external consultants, CMOs, CROs, and regulatory vendors.

⛳️ Requirements

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related scientific field; a minimum of 10 years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience.

• Expertise in technical CMC acquired through practical experience as a subject matter expert in one or more CMC disciplines, including formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality.

• Capability to independently analyze complex scientific and manufacturing data and convert technical conclusions into effective regulatory strategies.

• Significant hands-on experience in preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions.

• Comprehensive understanding of FDA and global CMC regulatory requirements throughout development and commercial stages.

• Experience in supporting small molecule drug products.

• Preferred experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies.

• Proven leadership in managing complex CMC regulatory activities, including interactions with health authorities.

• Ability to influence cross-functional teams, foster consensus among technical SMEs, and collaborate effectively with external manufacturing, testing, and other development partners.

• Ownership mindset with a proactive, can-do attitude and a strong commitment to excellence.

• Excellent project management, organizational, written, and verbal communication skills.

• Proficient in managing multiple programs and priorities effectively in a fast-paced, cross-functional environment.

• Skilled in utilizing AI tools and other digital technologies for document preparation, review, data analysis, and daily Regulatory CMC activities while ensuring scientific judgment, data integrity, confidentiality, and compliance with company policies.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-funded life insurance.

• AD&D benefits.

• Disability benefits.

• Voluntary plans to customize coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonus.

• Highly flexible wellness benefit.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.