Remote: Associate Director, CMC Reg Affairs (Small Molecules)

Ladders; United States; Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

401(k) match

Life insurance

Disability coverage

Paid time off

Wellness programs

Job summary

Ladders is seeking an Associate Director, CMC Regulatory Affairs - Small Molecules to join its pharmaceuticals regulatory team. The role shapes global CMC strategy across development and commercialization, partnering with cross-functional teams to guide submissions and manage regulatory risk while aligning quality and manufacturing readiness throughout the product lifecycle.

Location is remote, US-based candidates only, with compensation at $150,000–$195,000 per year.

Qualifications

• Bachelor’s degree required in a scientific discipline related to pharmaceuticals or biotech.
• 8+ years of Regulatory Affairs experience focusing on CMC activities.
• Experience leading Health Authority interactions and global CMC submissions.

Responsibilities

• Develop global CMC regulatory strategies for development and commercialization of small molecules.
• Lead cross-functional teams, providing strategic regulatory guidance throughout product development.
• Assess regulatory risks and formulate mitigation strategies to support business objectives.
• Drive global CMC regulatory submissions and engage with Health Authorities on CMC matters.
• Ensure compliance of CMC documentation with regional regulatory expectations.
• Support inspection readiness and provide regulatory oversight for manufacturing processes and product quality.
• Coordinate contributions to CMC submissions and manage changes for post-approval activities.

Skills

Regulatory Affairs

CMC knowledge

Leadership

Global submissions

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related

Job description

Ladders is seeking an Associate Director, CMC Regulatory Affairs - Small Molecules to join its pharmaceuticals regulatory team. The role shapes global CMC strategy across development and commercialization, partnering with cross-functional teams to guide submissions and manage regulatory risk while aligning quality and manufacturing readiness throughout the product lifecycle.

Location is remote, US-based candidates only, with compensation at $150,000–$195,000 per year.