Remote Global Senior Director, Regulatory CMC

Ladders; United States; Remote; USD 222,000 - 303,000; Full time

Benefits offered by this job

Medical coverage (comprehensive)

Dental coverage (comprehensive)

Vision coverage (comprehensive)

Paid time off

Flexible schedules

401(k) plan with company match

Equity awards

Learning institute access

Employee resource groups

Volunteer opportunities

Job summary

Ladders is seeking a Senior Director, Regulatory Affairs CMC to lead global regulatory CMC strategy for development and commercialization across both small- and large-molecule products. You will partner with cross-functional teams and regulatory agencies to support approvability, manage complex submissions, and help resolve technical issues.

This senior leadership role requires strategic oversight and hands-on leadership in a highly regulated global environment, with US-based remote eligibility.

Qualifications

• Bachelor's degree required; advanced degree preferred (MS, PhD, or PharmD).
• 10+ years of experience in pharmaceutical development and regulatory CMC.
• Experience with both small- and large-molecule products in multinational companies.
• Solid understanding of US, EU, and Japanese drug regulations.
• Proven ability to liaise with regulatory agencies.
• Strong project management skills within RA CMC.
• Excellent communication skills for presenting ideas and influencing outcomes.

Responsibilities

• Plan, execute, and manage regulatory submissions for clinical development and marketing applications
• Identify gaps and challenges in CMC development for global drug product approvability
• Conduct due diligence assessments of potential drug products
• Develop plans for CMC meetings with regulatory agencies and draft necessary documents
• Interpret FDA, EMA, ICH, and WHO regulations to ensure compliance in filings
• Communicate regulatory CMC requirements to team members
• Contribute to scientific discussions to resolve technical and regulatory issues

Skills

Regulatory CMC experience

Small- and large-molecule experience

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

MS/PhD/PharmD

Job description

Ladders is seeking a Senior Director, Regulatory Affairs CMC to lead global regulatory CMC strategy for development and commercialization across both small- and large-molecule products. You will partner with cross-functional teams and regulatory agencies to support approvability, manage complex submissions, and help resolve technical issues.

This senior leadership role requires strategic oversight and hands-on leadership in a highly regulated global environment, with US-based remote eligibility.