[Hiring] Associate Director, Regulatory CMC @Praxis Precision Medicines, Inc.

Role Description

The Associate Director, Regulatory CMC will be responsible for the planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) programs. This role will work closely with cross-functional partners and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management activities.

The ideal candidate is a hands-on regulatory professional with strong CMC technical knowledge, a proactive ownership mindset, and a commitment to excellence, who thrives in a fast-paced biotech environment, takes full accountability for assigned programs, effectively partners with cross-functional teams, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes.

Primary Responsibilities

• Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director.
• Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements.
• Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams.
• Support health authority interactions including briefing documents and information request responses.
• Maintain regulatory compliance for CMC activities supporting clinical and commercial supply.
• Assist with post-approval change management, comparability assessments, manufacturing changes, and technology transfers.
• Manage external consultants, CMOs, CROs, and regulatory vendors.

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline.
• 10+ years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience.
• Demonstrated technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines (e.g., formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality).
• Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions.
• Strong knowledge of FDA and global CMC regulatory requirements across development and commercial stages.
• Experience supporting small molecule drug products; experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred.
• Demonstrated leadership of complex CMC regulatory activities, including health authority interactions.
• Demonstrated ownership mindset with a proactive, can-do attitude and strong commitment to excellence.
• Strong project management, organizational, written, and verbal communication skills.
• Proficiency in leveraging AI tools and other digital technologies to enhance document preparation, review, data analysis, and day-to-day Regulatory CMC activities.

Requirements

• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.
• Comfort with screen work, basic hand coordination, and focus.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Benefits

• 99% of the premium paid for medical, dental and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Extremely flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

Company Description

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.