Praxis Precision Medicines, Inc. · 4 days ago
Senior Manager/Associate Director, CMC Regulatory Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$163K/yr - $183K/yr
5+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Senior Manager, Regulatory CMC will be responsible for the planning, preparation, and execution of CMC regulatory activities for investigational and commercial products, collaborating with cross-functional teams and external vendors.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
Responsibilities
Support development and execution of global 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 to ensure accuracy, alignment, and readiness for submission
Support and participate in health authority interactions, including preparation of briefing documents, responses to information requests, and meeting logistics
Maintain regulatory compliance for CMC activities supporting clinical supply, commercial manufacturing, and ongoing product supply, including stability updates and annual reports
Assist with post-approval change management, including comparability assessments, manufacturing changes, and technology transfers
Manage and coordinate external consultants, CMOs, CROs, and regulatory vendors supporting CMC regulatory activities
Qualification
Required
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline
5+ years of Regulatory Affairs experience with a focus on CMC
Hands-on experience preparing and/or managing CMC sections of INDs and NDAs/BLAs
Experience supporting small molecule drug products
Familiarity with FDA and global regulatory CMC requirements across development and commercial stages
Experience working with external manufacturing and testing partners
Solid understanding of CMC regulatory requirements and expectations
Strong project management and organizational skills, with the ability to manage multiple priorities
Excellent written and verbal communication skills
Detail-oriented, collaborative, and proactive problem solver
Ability to work effectively in a cross-functional, matrixed environment
Preferred
advanced degree preferred
experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred
Benefits
99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage.
We match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-13
2026-01-11
Company data provided by crunchbase