Associate Director, Regulatory CMC New United States - Remote

Praxis Precision Medicines, Inc.; Northern (KY); Remote; USD 175,000 - 200,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of regulatory activities for small molecule and ASO programs. You will coordinate with cross-functional teams and external vendors to support global submissions.

The role demands hands-on CMC regulatory expertise, ownership mindset, and strong collaboration to ensure regulatory-compliant, high-quality outcomes in a fast-paced biotech environment.

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 or equivalent.

Responsibilities

• Support development and execution of CMC regulatory strategies for small molecule and ASO programs.
• Author, compile, and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs, BLAs, amendments).
• Coordinate CMC content development with Quality, Analytical, Development, and Manufacturing teams.
• Support health authority interactions including briefing documents and information requests.
• Maintain regulatory compliance for CMC activities supporting clinical and commercial supply.
• Assist with post-approval change management and manufacturing changes.
• Manage external consultants, CMOs, CROs, and regulatory vendors.

Skills

Regulatory CMC

FDA knowledge

Cross-functional leadership

Project management

Regulatory submissions

External partnerships

Regulatory strategy

Attention to detail

Communication

Education

Advanced degree in Chemistry/Pharmaceutical Sciences/ Chemical Engineering/ Biochemistry

Job description

Location: This position may be performed remotely but requires flexibility and a willingness to travel as needed.

Position Summary

The Associate Director, Regulatory CMC willbe responsible forthe 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 and Key Success Factors

• 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), with the ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies.
• Extensive hands‑on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions , with 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 , and the ability to influence cross‑functional teams, build consensus among technical SMEs, and effectively work with external manufacturing, testing, and other development partners.
• Demonstrated ownership mindset with a proactive, can‑do attitude and strong commitment to excellence ; takes full accountability for assigned Regulatory CMC programs, anticipates and independently resolves complex issues, and consistently delivers high‑quality, scientifically sound, and regulatory‑compliant outcomes.
• Strong project management, organizational, written, and verbal communication skills , with the ability to manage multiple programs and priorities effectively in a fast‑paced, cross‑functional environment.
• Proficiency in leveraging AI tools and other digital technologies to enhance document preparation, review, data analysis, and day‑to‑day Regulatory CMC activities while maintaining scientific judgment, data integrity, confidentiality, and compliance with company policies.

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. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

$175,000 - $200,000 USD

Compensation & Benefits At Praxis, we believe that taking care of our people (and

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.

Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.