Manager, Regulatory CMC
$120k/y-$170k/y
2 days ago
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HybridFull-timeMid
Summary
Compass Pathways plc is seeking a Manager, Regulatory CMC to join their team in New York City or remotely on the East Coast, USA. The role involves supporting the development and execution of the CMC regulatory strategy and authoring critical submissions for their investigational product.
About the Role
As a CMC Regulatory Manager, you will liaise with cross-functional teams to prepare and maintain CMC sections of submissions, respond to Health Authority queries, author and review regulatory submission documents, develop CMC strategies, and maintain knowledge of regulatory environments and procedures.
About You
Required:
- Bachelor's Degree in life sciences or engineering, or other technical discipline.
- 3+ years of experience in CMC regulatory specifically.
- Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, etc).
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.
- Experience in drug development processes and post-approval requirements.
- Excellent communication skills, both written and oral.
Preferred:
- Experience in developing CMC regulatory strategy.
Benefits
- Competitive base salary ranging from $120k–$170k.
- Eligibility for additional discretionary bonuses and equity.
- Comprehensive benefits package.
Compass Pathways
We are Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our first clinical development programme is researching investigational COMP360 psilocybin treatment for patients with treatment-resistant depression. We want to transform the patient experience in mental health care.
New York, United States