Associate Director, Regulatory CMC

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](mailto: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.