Senior Director, Regulatory Affairs - Client-Dedicated Embedded Role

Ladders; United States; Remote; USD 180,000 - 210,000; Full time

Benefits offered by this job

Health insurance

Dental and vision plans

Paid time off (PTO)

Tuition reimbursement

401(k) with company match

Employee Stock Purchase Plan

Job summary

The Ladders seeks a Senior Director, Regulatory Affairs for a client-dedicated embedded role in Pharmaceuticals & Biotech. Remote, US-based candidates only, with a focus on shaping global regulatory strategy across development programs.

You will lead regulatory activities from early development through major global submissions, with emphasis on oncology and novel modalities, interfacing with FDA/EMA and other health authorities.

Qualifications

• Bachelor's degree in a scientific, medical, pharmaceutical, or related discipline; advanced degree preferred.
• 15+ years of progressive regulatory affairs experience in biotechnology or pharmaceuticals.
• Extensive experience with global regulatory strategies from early to late-stage development.
• Proven ability to lead interactions with FDA and other global health authorities.
• Experience with oncology drug development or RNA therapeutics/novel modalities is highly desirable.

Responsibilities

• Serve as the senior regulatory lead within the client organization, providing strategic and operational regulatory leadership.
• Develop and execute global regulatory strategies for clinical and preclinical assets.
• Provide regulatory leadership for innovative therapeutic modalities, identifying risks and opportunities.
• Act as a primary regulatory advisor to senior leadership and cross-functional teams.
• Lead preparation for interactions with global health authorities, including the FDA and EMA.
• Oversee regulatory submissions, including INDs, amendments, and marketing applications.
• Coordinate regulatory activities with external vendors and ensure quality and accountability.

Skills

Regulatory leadership

Global regulatory strategies

INDs/CTAs

FDA interactions

Education

Bachelor's degree in science/related

Advanced degree preferred

Job description

For our client, we are seeking a Senior Director, Regulatory Affairs - Client-Dedicated Embedded Role to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will serve as the senior regulatory lead embedded with the client organization, providing strategic and operational guidance across development programs. You will shape global regulatory strategy for innovative therapeutics, partner closely with senior leaders and cross-functional teams, and help ensure strong execution from early development through major global submissions. The position calls for deep expertise in oncology and novel modalities, along with the ability to navigate complex interactions with global health authorities.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $180,000 – $210,000 annually

Responsibilities

• Serve as the senior regulatory lead within the client organization, providing strategic and operational regulatory leadership
• Develop and execute global regulatory strategies for clinical and preclinical assets
• Provide regulatory leadership for innovative therapeutic modalities, identifying risks and opportunities
• Act as a primary regulatory advisor to senior leadership and cross-functional teams
• Lead preparation for interactions with global health authorities, including the FDA and EMA
• Oversee regulatory submissions, including INDs, amendments, and marketing applications
• Coordinate regulatory activities with external vendors and ensure quality and accountability

Qualifications

• Bachelor's degree in a scientific, medical, pharmaceutical, or related discipline; advanced degree preferred
• 15+ years of progressive regulatory affairs experience in biotechnology or pharmaceuticals
• Extensive experience with global regulatory strategies from early to late-stage development
• Demonstrated experience with INDs/CTAs and major global regulatory submissions
• Strong oncology drug development experience is required or preferred
• Experience with RNA therapeutics or other novel modalities is highly desirable
• Proven ability to lead interactions with FDA and other global health authorities

Benefits

• Choice of national medical, dental, and vision plans, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually
• Paid parental leave and short- and long-term disability insurance
• Retirement savings programs, including a competitive 401(k) plan
• Employee Stock Purchase Plan (ESPP) allowing stock purchase at a discount

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.