- Hybrid
- Full-time · Manager
- $148K–$220K per year
- 8+ years
Lead global regulatory CMC activities for a clinical‑stage biotechnology company.
Compensation
The estimate full-time salary range for this role is between $148,000 to $220,000.
Responsibilities
- Develop and execute global regulatory CMC strategies
- Evaluate drug substance and product development plans
- Lead planning, authoring, review, and coordination of CMC content for global regulatory submissions
- Develop regulatory positions and prepare CMC responses
- Assess regulatory impact of manufacturing and analytical changes
Requirements
- Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or related scientific discipline
- Nice to have: Advanced degree (MS, PhD, PharmD, or equivalent)
- Nice to have: Oligonucleotides
- Nice to have: Peptides
- Nice to have: Conjugated therapeutics