Vice President, CMC Regulatory Affairs

Ladders; United States; À distance; USD 272 000 - 340 000; Plein temps

Avantages offerts par ce poste

Health insurance

Flexible time off

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus & equity

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory leadership

CMC regulatory

Submissions to FDA/EMA

Cross-functional collaboration

Leadership

Formation

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

Advanced degree preferred

Description du poste

For our client, we are seeking a Vice President, CMC Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space. This leadership role will shape and execute global CMC regulatory strategy across a development portfolio, with a strong focus on submissions, agency engagement, and cross-functional alignment. The position serves as the primary CMC regulatory voice with FDA, EMA, and other global health authorities while helping ensure dossier quality, readiness, and compliance with ICH and local requirements. The successful candidate will also build and lead a high-performing team, guide risk-based decisions, and partner closely with internal stakeholders and CDMO collaborators to support regulatory outcomes.

Location: Remote

Compensation: $272,000 – $340,000 annually

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

Qualifications

• 15+ years of biopharmaceutical industry experience, with 10+ years in Regulatory CMC
• Proven success in submissions to FDA and EMA
• Strong analytical skills to assess regulatory issues and data
• Demonstrated leadership ability in motivating teams
• Excellent communication skills for effective influence
• Adaptability to fast-paced environments with shifting priorities
• BS in Biochemistry, Biology, Chemistry, Engineering, or related field; advanced degree preferred

Benefits

• Comprehensive health coverage
• Flexible time off and paid holidays
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities and equity grants

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.