Director, Regulatory Affairs

Ladders; United States; Remote; USD 196,000 - 245,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) plan

Medical, dental, vision insurance

merit-based salary increases

Job summary

Ladders is seeking a Director, Regulatory Affairs to guide global regulatory activities across development programs. The role focuses on strategic planning, ensuring submissions are compliant and aligned with program goals, while collaborating with cross-functional teams and governance forums.

Location: Remote (United States). Compensation ranges from $195,900 to $244,900 annually, reflecting senior leadership responsibilities in Biotech/Pharma.

Qualifications

• Bachelor's degree in a related field required.
• Master's degree in a scientific discipline preferred.
• Minimum 10 years of relevant experience in the biotech or pharmaceutical industry.
• Proven success in pre-IND, IND, NDA, MAA, and CTD submissions and approvals.
• Experience in CNS development and familiarity with FDA and ICH regulations.

Responsibilities

• Lead the global regulatory team for assigned projects.
• Manage regional regulatory activities as a regional regulatory lead.
• Represent Regulatory Affairs in project team meetings.
• Plan and prepare regulatory submissions in collaboration with Regulatory Operations.
• Assess and communicate regulatory requirements to ensure compliance.
• Document interactions with regulatory authorities and outcomes.
• Provide strategic updates to project teams and governance boards.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic planning

Regulatory communications

Education

Bachelor's degree

Master's degree in a scientific discipline

Job description

For our client, we are seeking a Director, Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will guide global and regional regulatory activities across assigned development programs, helping ensure submissions are strategically planned, compliant, and aligned with program goals.

The position partners closely with cross‑functional project teams, regulatory operations, and governance forums to communicate requirements, track agency interactions, and support decision‑making throughout the development lifecycle.

With a focus on complex regulatory deliverables, the director will help advance programs from early development through major global submission milestones.

Location: Remote

Compensation: $195,900 – $244,900 annually

Responsibilities

• Lead the global regulatory team for assigned projects
• Manage regional regulatory activities as a regional regulatory lead
• Represent Regulatory Affairs in project team meetings
• Plan and prepare regulatory submissions in collaboration with Regulatory Operations
• Assess and communicate regulatory requirements to ensure compliance
• Document interactions with regulatory authorities and outcomes
• Provide strategic updates to project teams and governance boards

Qualifications

• Bachelor's degree in a related field required
• Master's degree in a scientific discipline preferred
• Minimum 10 years of relevant experience in the biotech or pharmaceutical industry
• Proven success in pre-IND, IND, NDA, MAA, and CTD submissions and approvals
• Experience in CNS development and familiarity with FDA and ICH regulations

Benefits

• Flexible paid time off and 11 paid holidays
• 80 hours of paid sick time upon hire and annually thereafter
• Participation in a 401(k) plan
• Medical, dental, vision, life, and disability insurance
• Opportunity for merit-based salary increases

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.