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Praxis Precision Medicines, Inc.

Associate Director, Regulatory CMC

Praxis Precision Medicines, Inc. · United States - Remote

Posted 21 days ago

or apply directly on Praxis Precision Medicines, Inc. 's site. We never take the application ourselves.

Is this posting real?

This role has been open
21 days
Praxis Precision Medicines, Inc. 's roles stay open a median of 42 days
Reposted
No
Salary listed
No
0% of Praxis Precision Medicines, Inc. 's roles list one
Ghost-job risk at Praxis Precision Medicines, Inc.
high
15 stale, 1 reposted of 36 open
Hiring momentum
45 roles opened in the last 90 days
↑ up vs. the prior 90 days
Last confirmed on the employer's board
2026-09-17

Measured from postings appearing on and disappearing from Praxis Precision Medicines, Inc. 's own greenhouse board since 2026-08-03. Full hiring picture for Praxis Precision Medicines, Inc. .

About this role

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.

Our read on this posting3.4out of 5
benefits
5/5
freshness
4/5
career value
4/5
role clarity
4/5
pay transparency
0/5

Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Praxis Precision Medicines, Inc. as an employer.

What you need

  • 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 you get

  • 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

Worth weighing

  • 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

Summarised from Praxis Precision Medicines, Inc. 's posting. Read the full original.

Listed by Praxis Precision Medicines, Inc. on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.

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