Regulatory Operations Lead - Remote, RIM & Submissions

ADC Therapeutics America Inc; New Providence (NJ); Remoto; USD 150.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus potential

Medical, Dental, Vision benefits

401(k) with match

Paid time off and holidays

Stock options

Descrizione del lavoro

ADC Therapeutics is seeking an Associate Director of Regulatory Operations (Remote) to lead regulatory submissions in the US and internationally, in collaboration with CROs. This hand-on role also maintains the RIM system and supports project management for regulatory submissions.

The position reports to the Head of Global Regulatory Affairs and may require some travel to the New Providence, NJ office. A strong background in Regulatory Operations and oncology drug development is preferred.

Competenze

• 7+ years in biotech/pharma research, incl. 5+ years in Regulatory Affairs Operations.
• Bachelor’s degree in a scientific discipline.
• Regulatory Operations support across all drug development phases.
• Experience managing RIM systems and HA electronic portals (CTIS).
• Experience supporting oncology drug development from Regulatory Operations.
• Team player with external CRO collaboration.
• Strong organizational and multitasking abilities.
• Excellent verbal and written communication skills.

Mansioni

• Hands-on tactical execution of Regulatory related systems.
• Act as Regulatory Information Management system owner for submissions.
• US: responsible person for RIM vendor interactions and ESG submissions.
• Non-US: responsible person for regional HA portals with CROs.
• Collaborate with CRO partners for global regulatory submissions.
• Establish and manage regulatory timelines from a PM perspective.
• Develop and maintain departmental processes, SOPs and documents.
• Other duties as assigned.

Conoscenze

Regulatory Operations

RIM systems

CTIS

Veeva

Oncology regulatory

Stakeholder collaboration

Multitasking

Communication skills

Formazione

Bachelor's degree in science

Strumenti

Veeva

CTIS

Descrizione del lavoro

ADC Therapeutics is seeking an Associate Director of Regulatory Operations (Remote) to lead regulatory submissions in the US and internationally, in collaboration with CROs. This hand-on role also maintains the RIM system and supports project management for regulatory submissions.

The position reports to the Head of Global Regulatory Affairs and may require some travel to the New Providence, NJ office. A strong background in Regulatory Operations and oncology drug development is preferred.