CMC Regulatory Consultant - Oligonucleotide Therapeutics
- Experience
- Lead
- Employment
- Contract
Open to US only. Set where you work from to check your eligibility.
No BS summary
Experienced CMC regulatory consultant in pharma/biotech with 10+ years, deep oligonucleotide therapeutics expertise, and IND CMC submission experience. Must be United States-based remote and strong on FDA CMC regulations, CDMOs, and regulatory strategy.
We're seeking an experienced CMC Regulatory Consultant to provide strategic regulatory leadership for the development of an innovative therapeutic utilizing advanced oligonucleotide and targeted intracellular drug delivery technologies. This is an opportunity to work alongside a cutting-edge development team, helping shape CMC strategy from early development through IND submission while supporting groundbreaking science. Compensation: $250 per hour What You'll Do Provide strategic CMC regulatory guidance throughout product development. Review and advise on drug substance, drug product, manufacturing, analytical methods, and control strategies. Lead or contribute to IND CMC sections, FDA briefing packages, and regulatory responses. Identify regulatory risks and recommend practical mitigation strategies. Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones. Requirements What We're Looking For Advanced scientific degree (PhD, PharmD, MS, or equivalent). 10+ years of CMC regulatory experience within pharmaceutical or biotechnology organizations. Deep expertise supporting oligonucleotide therapeutics (antisense oligonucleotides, siRNA, RNA therapeutics, or related technologies). Extensive experience authoring or reviewing IND CMC submissions . Strong knowledge of FDA CMC regulations and regulatory strategy. Experience working with CDMOs and multidisciplinary development teams. Preferred: Experience with targeted intracellular or endosomal drug delivery technologies. Prior FDA regulatory experience or senior CMC leadership. Background supporting successful IND submissions. If you're a strategic regulatory expert who thrives at the intersection of innovative science and regulatory excellence, we'd love to hear from you. Benefits This position does not qualify for benefits. MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
What you'll do
- Provide strategic CMC regulatory guidance throughout product development.
- Review and advise on drug substance, drug product, manufacturing, analytical methods, and control strategies.
- Lead or contribute to IND CMC sections, FDA briefing packages, and regulatory responses.
- Identify regulatory risks and recommend practical mitigation strategies.
- Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones.
What they require
- Advanced scientific degree (PhD, PharmD, MS, or equivalent).
- 10+ years of CMC regulatory experience within pharmaceutical or biotechnology organizations.
- Deep expertise supporting oligonucleotide therapeutics (antisense oligonucleotides, siRNA, RNA therapeutics, or related technologies).
- Extensive experience authoring or reviewing IND CMC submissions.
- Strong knowledge of FDA CMC regulations and regulatory strategy.
- Experience working with CDMOs and multidisciplinary development teams.
- Preferred: Experience with targeted intracellular or endosomal drug delivery technologies.
- Preferred: Prior FDA regulatory experience or senior CMC leadership.
- Preferred: Background supporting successful IND submissions.
Benefits
- This position does not qualify for benefits.