Global Regulatory Submissions Lead

ADC Therapeutics SA; Fully; Remote; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental and Vision benefits

401(k) with company match

Paid time off and holidays

Job summary

ADC Therapeutics SA in Switzerland is seeking a Regulatory Operations leader to oversee RIM systems and global submissions. The role reports to the Head of Global Regulatory Affairs and offers remote flexibility.

You will coordinate US and non-US regulatory submissions with CROs, manage timelines, and help shape processes to accelerate oncology programs. Travel to partner offices may be required.

Join a mission-driven biotech with a collaborative culture and competitive benefits.

Qualifications

• 7+ years’ experience in a biotech/pharmaceutical research environment, including 5+ years in Regulatory Affairs Operations.
• Minimum of a Bachelor’s degree in a scientific discipline
• Experience in Regulatory Operational support to all phases of drug development
• Experience in management of RIM systems, and HA electronic portals (eg CTIS), VEEVA experience preferred.
• Experience in supporting oncology drug development programs from a Regulatory Operations perspective
• Team player who can collaborate and work successfully with multiple key stakeholders including external CROs
• Ability to successfully handle multiple, competing tasks
• Strong verbal and written communication skills
• Requires a highly motivated, resourceful, individual who can set goals, shift priorities, work independently and collaborate effectively with project teams
• Good organizational skills and attention to detail

Responsibilities

• Act as the Regulatory Information Management (RIM) system owner for regulatory submissions.
• US: Act as the ADCT responsible person for all activities with the RIM vendor (system upgrades, compliance etc) and submissions through the ESG.
• Non-US: Act as the responsible person for regional Health Authority RIM systems on behalf of ADCT (e.g. CTIS) through collaboration with external CROs.
• Collaborate with CRO partners for global regulatory submissions.
• Establish and manage regulatory timelines from a project management perspective.
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.
• Other duties as assigned

Skills

Regulatory Operations

RIM systems

CTIS familiarity

Veeva experience

Oncology drug development

Stakeholder collaboration

Multi-tasking

Strong communication

Education

Bachelor's degree in science

Job description

ADC Therapeutics SA in Switzerland is seeking a Regulatory Operations leader to oversee RIM systems and global submissions. The role reports to the Head of Global Regulatory Affairs and offers remote flexibility.

You will coordinate US and non-US regulatory submissions with CROs, manage timelines, and help shape processes to accelerate oncology programs. Travel to partner offices may be required.

Join a mission-driven biotech with a collaborative culture and competitive benefits.