HHiring Reality
← Praxis Precision Medicines, Inc.

Associate Director, Regulatory CMC

Praxis Precision Medicines, Inc.
Location
United States - Remote
Posted
25 days ago
Department
Regulatory
What they actually want (must-haves)
  • 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
  • Demonstrated technical CMC expertise as a subject matter expert in one or more CMC disciplines
  • Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions
  • Strong knowledge of FDA and global CMC regulatory requirements
  • Experience supporting small molecule drug products
Nice to have
  • Experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies
What the job really is

The Associate Director, Regulatory CMC will oversee the planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, particularly small molecules and antisense oligonucleotides. This role involves collaborating with cross-functional teams and external vendors to support global regulatory submissions and health authority interactions, ensuring compliance and managing post-approval activities.

Benefits
  • Annualized Base Salary of $175,000 — $200,000 USD
  • 99% of the premium paid for medical, dental and vision plans
  • Company-paid life insurance, AD&D, disability benefits
  • 401(k) matching dollar-for-dollar up to 6%
  • Long-term stock incentives and ESPP
  • Discretionary quarterly bonus
Things to weigh
  • Remote position requires flexibility and willingness to travel as needed
  • Fast-paced biotech environment may demand high accountability and proactive problem-solving
  • No specific mention of career advancement opportunities or training programs
Job score3.4/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

Applying to Praxis Precision Medicines, Inc. ?

See how your résumé matches this role — and tailor it from what actually gets interviews.