Senior Manager – CMC Regulatory Affairs
Praxis
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $163,000 - $183,000 per year
Job Level
About the role
- 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
Requirements
- Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (advanced degree preferred)
- 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; experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred
- 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
Benefits
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance
- AD&D and disability benefits
- Voluntary plans to personalize coverage
- 401(k) matching up to 6%
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous PTO
- Paid holidays and company-wide shutdowns
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsCMCINDsIMPDsNDAsBLAscomparability assessmentstechnology transfersstability updatespost-approval change management
Soft Skills
project managementorganizational skillswritten communicationverbal communicationdetail-orientedcollaborativeproactive problem solvingability to manage multiple prioritiescross-functional teamworkmatrixed environment
Certifications
Bachelor’s degreeMaster’s degree