Senior Manager, CMC Regulatory Affairs - Small Molecules

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Premium health

Well-being offerings

Wellness programs

Life insurance

Disability

Retirement match

Generous PTO

Job summary

Scorpion Therapeutics in San Diego, CA seeks a Senior Manager, CMC Regulatory Affairs to provide strategic and operational leadership for CMC activities across development and commercialization of small molecule oral solid dosage forms.

You will lead cross-functional regulatory guidance, shape IND-to-approval strategies, author Module 2/3 CMC documentation, and liaise with Health Authorities while traveling ~10% and maintaining onsite collaboration.

Qualifications

• Bachelor’s degree required; MS/PhD/PharmD preferred.
• 7+ years Regulatory Affairs in pharma/biotech with significant CMC experience.
• Strong experience with small molecule IND-to-commercialization and lifecycle management.
• Demonstrated CMC submission experience; global/regional agency experience (FDA, EMA, GCC, PMDA).

Responsibilities

• Develop and execute CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
• Lead cross-functional CMC regulatory guidance; partner with Development, Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and PM.
• Assess regulatory risks; develop mitigation strategies and recommendations.
• Support IND through NDA approval and post-approval lifecycle management.
• Lead preparation/review/submission of CMC documents (INDs, CTAs, IMPDs, NDAs, MAAs, variations, annual reports, health authority responses).
• Author/review Module 2 and Module 3 CMC documentation.
• Support initial marketing applications/registration strategies; Health Authority interactions; inspection readiness.
• Plan and support post-approval CMC changes (process/formulation/specification/analytical methods/site transfers/tech transfers/validation/stability/supplier changes).

Skills

Leadership

Ownership

Travel ~10%

Onsite in San Diego

Education

Bachelor’s degree in a related scientific field

MS/PhD/PharmD preferred

Job description

Position Summary:

Senior Manager, CMC Regulatory Affairs. Provide strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs for small molecule drug products, primarily oral solid dosage forms (tablets/capsules).

Responsibilities:

• Develop and execute CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management.
• Lead cross-functional CMC regulatory guidance; partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management.
• Assess regulatory risks; develop mitigation strategies and recommendations.
• Support IND through NDA approval and post-approval lifecycle management (including expedited pathways where applicable).
• Lead preparation/review/submission of CMC regulatory documents (INDs, CTAs, IMPDs, NDAs, MAAs, amendments/supplements, variations, annual reports, Health Authority question responses).
• Author/review Module 2 and Module 3 CMC documentation.
• Support initial marketing applications/registration strategies; Health Authority interactions; inspection readiness.
• Plan and support post-approval CMC changes (process/formulation/specification/analytical method/site transfers/technology transfers/validation/stability/supplier changes).

Qualifications:

• Bachelor’s degree in a related scientific field required; MS/PhD/PharmD preferred.
• 7+ years Regulatory Affairs in pharma/biotech with significant CMC Regulatory Affairs experience.
• Strong experience with small molecule products IND-to-commercialization and post-approval lifecycle management; extensive oral solid dosage form experience.
• Demonstrated CMC submission experience; global/regional agency experience (FDA, EMA, GCC, PMDA).

Additional skills:

leadership, independent ownership, ability to travel ~10%, and not 100% remote (onsite/face-to-face in San Diego required).

Benefits:

• premium health
• financial/work-life/well-being offerings
• wellness programs
• life insurance
• disability
• retirement match
• and generous paid time off.