Associate Director, Regulatory CMC

Regulatory Jobs; United States; Remote; USD 175,000 - 200,000; Full time

Benefits offered by this job

Premium medical/dental/vision coverage

Company-paid life insurance

AD&D

Disability benefits

401(k) match

Stock incentives

ESPP

Quarterly bonus

Flexible wellness benefit

Generous PTO

Holidays and company-wide shutdowns

Job summary

Praxis Precision Medicines seeks an Associate Director, Regulatory CMC to lead planning, preparation, and execution of CMC regulatory activities for both investigational and commercial programs. The role collaborates with cross-functional teams and vendors to support global submissions, health authority interactions, and lifecycle management.

The ideal candidate has hands-on CMC expertise, ownership mindset, and can deliver scientifically sound regulatory outcomes in a fast-paced biotech

Qualifications

• Bachelor’s/Master’s/Ph.D. in a relevant science with 10+ years in Regulatory CMC or equivalent.
• Hands-on CMC SME with ability to interpret complex data and craft regulatory strategies.
• Experience preparing and managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions.
• Experience supporting small molecule and ASO programs; FDA and global CMC knowledge.
• Proven leadership of complex CMC activities and health authority interactions.

Responsibilities

• Develop and execute CMC regulatory strategies for INDs/NDAs/BLAs and post-approval changes.
• Author, compile, and review CMC sections across regulatory submissions.
• Coordinate content development with Quality, Analytical, Development, and Manufacturing teams.
• Support health authority interactions with briefing documents and information requests.
• Maintain regulatory compliance for CMC activities supporting clinical and commercial supply.
• Manage external consultants, CMOs, CROs, and regulatory vendors.
• Lead post-approval changes, comparability assessments, and tech transfers.

Skills

CMC regulatory

Regulatory leadership

Regulatory submissions

Cross-functional collaboration

Project management

AI tools in docs

Education

Advanced degree in Chemistry/Pharmaceutical Sciences

Tools

Regulatory databases

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.
• Assistwith post-approval change management, comparability assessments, manufacturing changes, and technology transfers.
• Manage external consultants, CMOs, CROs, and regulatory vendors.

Qualifications and Key SuccessFactors

• 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.
• Demonstratedtechnical CMC expertise gained through hands-on experience as a subject matter expertin one or more CMC disciplines (e.g., formulation, analytical development, process development, manufacturing, chemistry, pharmaceuticaldevelopment, 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 forINDs, IMPDs, NDAs, BLAs, and post-approval submissions, withstrongknowledge of FDA and global CMC regulatory requirements across development and commercial stages.
• Experience supportingsmall molecule drug products; experience withantisense oligonucleotides (ASOs) or other oligonucleotide-based therapiesis strongly preferred.
• Demonstratedleadership of complex CMC regulatory activities, includinghealth 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.
• Demonstratedownership mindset with a proactive, can-do attitude and strong commitment to excellence; takes full accountability for assigned Regulatory CMC programs,anticipatesand independently resolves complex issues, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes.
• Strongproject management, organizational, written, and verbal communication skills, with the ability to manage multiple programs and priorities effectively in a fast-paced, cross-functional environment.
• ProficiencyinleveragingAI tools and other digital technologiesto enhance document preparation, review, data analysis, and day-to-day Regulatory CMC activities whilemaintainingscientific 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.

Annualized Base Salary

$175,000—$200,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

Company Overview

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.