Remote Senior Director, Regulatory Affairs – Oncology

Ladders; United States; À distance; USD 180 000 - 210 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental and vision plans

Paid time off (PTO)

Tuition reimbursement

401(k) with company match

Employee Stock Purchase Plan

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory leadership

Global regulatory strategies

INDs/CTAs

FDA interactions

Formation

Bachelor's degree in science/related

Advanced degree preferred

Description du poste

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.