Vice President, Regulatory Affairs

Ladders; United States; À distance; USD 280 000 - 340 000; Plein temps

Avantages offerts par ce poste

Health insurance

Home office equipment stipend

Learning budget $1,200/year

Wellness budget $250/month

4-day weekends

Unlimited vacation and holidays

Paw-ternity leave

Company equity options

Résumé du poste

Ladders is seeking a Vice President of Regulatory Affairs to shape regulatory strategy across the development portfolio. The role partners with executive leadership, manufacturing partners, and cross-functional teams to guide submissions, manage risk, and strengthen global regulatory execution.

The ideal candidate has deep experience in small molecule drug development and post-approval regulatory activities. Location: Remote - US based candidates only, no visa sponsorship available.

Qualifications

• Ph.D. required in a relevant field (Pharmaceutical Sciences, Chemical Engineering, Chemistry) or equivalent experience.
• ≥18 years in regulatory affairs within pharma/biotech, with ≥10 years in senior leadership.
• Strong CMC regulatory background with small molecule drug development expertise.
• Proven track record leading integrated regulatory teams across CMC and clinical functions.

Responsabilités

• Drive regulatory strategy across all programs, integrating CMC and clinical plans.
• Provide regulatory input for portfolio planning and business development activities.
• Develop global regulatory intelligence capabilities to inform strategy.
• Update executive leadership on submission progress and regulatory risks.
• Lead CMC regulatory activities, including filing strategy and oversight of manufacturing partners.
• Manage clinical regulatory activities, including IND strategy and protocol review.
• Establish and scale regulatory governance frameworks and procedural documents.

Connaissances

Regulatory strategy

CMC regulatory

NDA/MAA submissions

Leadership

Formation

Ph.D. in Pharmaceutical Sciences / Chemical Engineering / Chemistry

Description du poste

For our client, we are seeking a Vice President, Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space.
This leader will shape regulatory strategy across the development portfolio, aligning CMC and clinical plans to support program advancement and long-term business goals. The role will partner closely with executive leadership, manufacturing partners, and cross-functional stakeholders to guide submissions, manage risk, and strengthen global regulatory execution. The ideal candidate will bring deep expertise in small molecule drug development, integrated regulatory leadership, and post-approval change management within a highly regulated biotech environment.
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $280,000 – $340,000 annually

Responsibilities

• Drive regulatory strategy across all programs, integrating CMC and clinical plans.
• Provide regulatory input for portfolio planning and business development activities.
• Develop global regulatory intelligence capabilities to inform strategy.
• Update executive leadership on submission progress and regulatory risks.
• Lead CMC regulatory activities, including filing strategy and oversight of manufacturing partners.
• Manage clinical regulatory activities, including IND strategy and protocol review.
• Establish and scale regulatory governance frameworks and procedural documents.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field, or equivalent experience.
• 18+ years of regulatory affairs experience within pharma/biotech, including 10+ years in senior leadership roles.
• Strong CMC regulatory background with expertise in small molecule drug development.
• Proven track record of leading integrated regulatory teams across CMC and clinical functions.
• Experience bringing at least one product to regulatory approval, including NDA or MAA submissions.
• Demonstrated experience in post-approval regulatory activities and change management.
• Strong knowledge of ICH guidelines and global regulatory requirements.

Benefits

• Full-coverage health insurance for you and your dependents.
• $1,000 home office equipment stipend.
• $1,200/year learning budget for professional development.
• $250/month wellness budget for personal care and fitness.
• All 3-day weekends become 4-day weekends.
• Unlimited vacation and paid holidays.
• Paw-ternity leave for adopting a dog.
• Company equity options grant for new hires.

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.