Senior Manager/Associate Director, CMC Regulatory Affairs

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

The Senior Manager, 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 who thrives in a fast-paced biotech environment and is comfortable managing multiple programs across different stages of development.

Primary 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.

Qualifications and Key Success Factors

• 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

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.

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!

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.