--- title: 'Associate Director, Regulatory CMC at Praxis Precision Medicines, Inc.' canonical: 'https://feeny.ai/job/associate-director-regulatory-cmc-praxis-precision-medicines-inc-united-states-e2y1dazam5bd' type: 'job' last_seen: '2026-09-06' --- # Associate Director, Regulatory CMC at Praxis Precision Medicines, Inc. - **Company:** Praxis Precision Medicines, Inc. - **Location:** United States - **Compensation:** $175k–$200k - **Work type:** remote - **Posted:** 2026-08-26 - **Last confirmed live:** 2026-09-06 - **Apply:** https://job-boards.greenhouse.io/praxisprecisionmedicines/jobs/5399467008 ## 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 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 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. 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. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. ## About Praxis Precision Medicines, Inc. ## Company Overview - **One-liner**: Praxis Precision Medicines is a fully integrated, clinical-stage biopharmaceutical company developing precision therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance. - **Entity Type**: Public (NASDAQ: PRAX) - **Headquarters**: Boston, Massachusetts, United States - **Founded**: 2015 - **Founders**: Dr. Steven Petrou (Co-Founder and President of R&D) ## Core Business - **Primary Industry**: Biotechnology (CNS / Neuroscience) - **Target Customers**: Patients with rare and prevalent neurological disorders (e.g., essential tremor, developmental and epileptic encephalopathies, focal epilepsy); healthcare providers; payers. - **Mission / Purpose**: To translate genetic insights into the development of life-altering therapies for CNS disorders more effectively and efficiently. ## Products & Services Praxis operates two proprietary platforms and a pipeline of late-stage and early-stage programs: - **Cerebrum™ (Small Molecule Platform)**: Orally available precision therapies targeting ion channels and neuronal circuits. Key assets include: - **Ulixacaltamide**: A T-type calcium channel inhibitor for essential tremor (ET). NDA submission to the FDA expected by mid-February 2026. Breakthrough Therapy Designation. - **Relutrigine**: For SCN2A- and SCN8A-developmental and epileptic encephalopathies (DEEs). NDA submission expected by mid-February 2026. Breakthrough Therapy Designation. Also in Phase 3 for broad DEEs. - **Vormatrigine**: A sodium-channel modulator for focal onset seizures (FOS). In Phase 3 trials (POWER1, POWER2). - **Solidus™ (Antisense Oligonucleotide Platform)**: For genetically defined CNS disorders. Key asset: - **Elsunersen**: An ASO designed to reduce SCN2A gene expression for early-seizure-onset SCN2A-DEE. In Phase 3 (EMBRAVE3). Orphan Drug Designation. - **Early-Stage Pipeline**: Preclinical candidates (PRAX-020, PRAX-080, PRAX-090, PRAX-100) targeting other genetic epilepsies and neurodevelopmental disorders. ## Market Standing - **Market Cap**: ~$156.0 million (as of mid-2026 data) [linkedin.com] - **Key Metric (Revenue/Funding)**: Annual revenue reported at ~$8.6M (pre-commercial stage). Pro forma cash, cash equivalents, and marketable securities stand at **$1.5 billion** following a public offering in January 2026 that raised ~$621 million [ir.praxismedicines.com]. - **Notable Investors/Partners**: Ionis Pharmaceuticals, Inc. (collaboration on elsunersen); RogCon, Inc. (license agreement). - **Growth Signals**: - Rapidly scaling headcount: 166 employees (+49.7% year-over-year) [linkedin.com]. - Transformation to a commercial-stage company: Preparing for two NDA submissions by mid-February 2026. - Combined peak revenue estimates for its four late-stage assets expected to exceed **$20 billion** [ir.praxismedicines.com]. - Active hiring: 31 open positions in mid-2026 (up 933% year-over-year) [linkedin.com]. ## Competitive Advantages - **Precision Neuroscience Moat**: Deep understanding of shared biological targets and circuits in the brain derived from genetic epilepsies. - **Proprietary Dual Platforms**: Leveraging both small molecule (Cerebrum) and ASO (Solidus) modalities to address a wide range of CNS disorders. - **Breakthrough Therapy Designations**: Both lead assets (ulixacaltamide, relutrigine) have FDA Breakthrough Therapy Designation, accelerating development and review. - **Strong Cash Position**: $1.5 billion pro forma cash provides a long runway through multiple potential product launches and pipeline expansion. - **Late-Stage Pipeline**: Four late-stage product candidates approaching potential commercial launch, de-risking the company substantially. ## Strategic Focus - **Commercial Launch Readiness**: Building out commercial infrastructure, sales force, and patient support programs in parallel with regulatory submissions. - **Pipeline Expansion**: Declaring multiple new drug candidates from both Cerebrum and Solidus platforms in 2026. - **Lifecycle Management**: Exploring indication expansion for existing assets (e.g., relutrigine in broad DEEs via the EMERALD study; vormatrigine for monotherapy FOS). - **Global Reach**: Operating in 5 countries (US, Australia, India, Colombia, Brazil) with a growing workforce. ## Why Work Here - **Mission-Driven Work**: Opportunity to deliver transformative therapies to patients with severe, underserved CNS disorders. - **Growth Trajectory**: The company is at a pivotal inflection point, transitioning from a clinical-stage to a commercial-stage organization — offering dynamic career growth. - **Remote-First Culture**: The vast majority of open positions across all departments (Clinical, Medical, Commercial, Finance, Legal, etc.) are listed as **"United States - Remote"** [greenhouse.io]. This includes roles like Director, Commercial Compliance; Senior Clinical Trial Manager; and Director, Field Reimbursement. - **Global Talent**: Engineering and technical roles are open internationally (e.g., Software Engineer in Brazil) [greenhouse.io]. - **Strong Leadership**: Recent appointments of experienced pharmaceutical executives (Jeffrey B. Kinder, Stuart Arbuckle) and internal promotions (Megan Sniecinski to COO). - **Compensation**: Employee reviews indicate a strong **Compensation rating of 4.0/5.0**, though overall culture and career ratings are lower (2.8 and 2.7 respectively on LinkedIn) [linkedin.com]. - **Workforce Demographics**: A high proportion of Director-level roles are open (20% of workforce), alongside specialists and senior IC roles, suggesting significant opportunities for leadership-level hires. ## Sources 1. [greenhouse.io](http://job-boards.greenhouse.io/praxisprecisionmedicines) - Jobs at Praxis Precision Medicines, Inc. 2. [ir.praxismedicines.com](https://ir.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-enters-its-next-chapter-following) - Press Release: Business Outlook and Priorities for 2026 3. [linkedin.com](https://www.linkedin.com/company/praxis-precision-medicines-inc) - LinkedIn Company Profile 4. [stockanalysis.com](https://stockanalysis.com/stocks/prax/company/) - Company Profile & Key Executives ## Other roles at Praxis Precision Medicines, Inc. - [Associate Director, Regulatory Affairs, AD Promo](https://feeny.ai/job/associate-director-regulatory-affairs-ad-promo-praxis-precision-medicines-inc-knjtsbdgq5rn) — United States - [Medical Information Specialist](https://feeny.ai/job/medical-information-specialist-praxis-precision-medicines-inc-united-states-p7f0w7ye8d61) — United States - [Clinical Medical Monitor](https://feeny.ai/job/clinical-medical-monitor-praxis-precision-medicines-inc-united-states-aycaavkze79q) — United States - [Manager, Analytical Sciences - Commercial](https://feeny.ai/job/manager-analytical-sciences-commercial-praxis-precision-medicines-inc-united-fj5ctas3k0w2) — United States - [Director, Medical Science Liaisons](https://feeny.ai/job/director-medical-science-liaisons-praxis-precision-medicines-inc-united-states-bhakzbah9dvw) — United States - [Computer Systems Validation Engineer](https://feeny.ai/job/computer-systems-validation-engineer-praxis-precision-medicines-inc-united-84kqsazb917h) — United States - [Clinical Development Leader, Lifecycle Management](https://feeny.ai/job/clinical-development-leader-lifecycle-management-praxis-precision-medicines-inc-hvv6gtsjkytp) — United States - [Clinical Development Leader, Epilepsies](https://feeny.ai/job/clinical-development-leader-epilepsies-praxis-precision-medicines-inc-united-ywq6h858ygqj) — United States - [Clinical Development Leader, Movement Disorders](https://feeny.ai/job/clinical-development-leader-movement-disorders-praxis-precision-medicines-inc-ysgcsw94ftfc) — United States - [Director of Toxicology](https://feeny.ai/job/director-of-toxicology-praxis-precision-medicines-inc-united-states-byns05gz4490) — United States