Remote Associate Director, Regulatory Operations (Biotech)

ADC Therapeutics SA; New Providence (NJ); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision benefits

401(k) with company match

Paid time off and company holidays

New hire stock options

Job summary

ADC Therapeutics is seeking an Associate Director, Regulatory Operations (U.S. Remote) to lead regulatory submissions in the US and international regions, in collaboration with CROs.

The role reports to the Head of Global Regulatory Affairs and supports RIM system optimization and project management for submissions. You will act as the Regulatory Information Management system owner, coordinate timelines, ensure compliance with HA portals (eg CTIS), and work with external partners to drive timely

Qualifications

• 7+ years in biotech/pharmaceutical research with 5+ years in Regulatory Affairs Operations
• Bachelor’s degree in a scientific discipline
• Experience in Regulatory Operational support across drug development
• Experience in managing RIM systems and HA portals (CTIS)
• Experience in oncology drug development from Regulatory Ops perspective
• Ability to collaborate with CROs and stakeholders
• Strong verbal and written communication skills

Responsibilities

• Hands-on execution of Regulatory related systems
• Own RIM system responsibilities for regulatory submissions
• Coordinate US activities with RIM vendor and ESG submissions
• Oversee regional RIM systems (eg CTIS) with CRO collaboration
• Collaborate with CRO partners for global regulatory submissions
• Establish and manage regulatory timelines from a PM perspective
• Assist in developing and maintaining departmental processes and SOPs
• Other duties as assigned

Skills

Regulatory operations

Project management

Communication

Team collaboration

Education

Bachelor’s degree in science

Tools

RIM systems

CTIS

Veeva

Job description

ADC Therapeutics is seeking an Associate Director, Regulatory Operations (U.S. Remote) to lead regulatory submissions in the US and international regions, in collaboration with CROs.

The role reports to the Head of Global Regulatory Affairs and supports RIM system optimization and project management for submissions. You will act as the Regulatory Information Management system owner, coordinate timelines, ensure compliance with HA portals (eg CTIS), and work with external partners to drive timely