Remote VP, Global CMC Regulatory Affairs

Ladders; United States; Remote; USD 272,000 - 340,000; Full time

Benefits offered by this job

Health insurance

Flexible time off

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus & equity

Job summary

Ladders is seeking a Vice President, CMC Regulatory Affairs to shape and execute global CMC regulatory strategy across a development portfolio. This leadership role focuses on submissions, agency engagement, and cross-functional alignment, serving as the primary CMC regulatory voice with FDA, EMA, and other authorities while ensuring dossier quality and compliance.

You will build and lead a high-performing team, guide risk-based decisions, and partner with internal stakeholders and CDMO

Qualifications

• 15+ years in biopharma with 10+ years in Regulatory CMC.
• Proven success in FDA and EMA submissions.
• Strong analytical skills for regulatory issues.
• Proven leadership ability to motivate teams.
• Excellent communication for effective influence.
• Adaptability to fast-paced environments with shifting priorities.
• BS in Biochemistry/Biology/Chemistry/Engineering or related field; advanced degree preferred.

Responsibilities

• Develop and own global CMC regulatory strategy for the portfolio.
• Serve as the lead CMC voice with FDA, EMA, and global health authorities.
• Ensure execution of CMC regulatory strategy.
• Set standards for submission quality and team accountability.
• Build and lead a high-performing CMC Regulatory team.
• Oversee CMC-related submission planning and execution.
• Interpret and discuss data with cross-functional teams and health authorities.
• Anticipate regulatory expectations and advise leadership.
• Lead risk assessments on CMC regulatory topics.
• Establish strategic relationships with CDMO partners and health authorities.
• Ensure CMC dossiers meet ICH and local requirements.
• Determine resourcing and budget for CMC Regulatory.

Skills

Regulatory leadership

CMC regulatory

Submissions to FDA/EMA

Cross-functional collaboration

Leadership

Education

BS in Biochemistry/Biology/Chemistry/Engineering or related field

Advanced degree preferred

Job description

Ladders is seeking a Vice President, CMC Regulatory Affairs to shape and execute global CMC regulatory strategy across a development portfolio. This leadership role focuses on submissions, agency engagement, and cross-functional alignment, serving as the primary CMC regulatory voice with FDA, EMA, and other authorities while ensuring dossier quality and compliance.

You will build and lead a high-performing team, guide risk-based decisions, and partner with internal stakeholders and CDMO