Associate Director, Regulatory Operations

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Carry out regulatory submissions both in the US and internationally in partnership with CROs.

• Enhance and sustain ADC Therapeutics’ Regulatory Information Management (RIM) system.

• Offer project management assistance for the assembly of regulatory submissions.

• Function as the RIM system owner overseeing all regulatory submissions.

• Act as the designated ADCT representative for RIM vendor operations, including system upgrades, compliance, and submissions via the ESG.

• Be the point of contact for regional Health Authority RIM systems, such as CTIS, by working closely with external CROs.

• Collaborate with CRO partners regarding global regulatory submissions.

• Set up and manage regulatory timelines from a project management viewpoint.

• Aid in the development and upkeep of departmental processes, policies, SOPs, and related documentation.

• Undertake additional duties as assigned.

⛳️ Requirements

• Over 7 years of experience in a biotech or pharmaceutical research setting.

• More than 5 years of experience in Regulatory Affairs Operations.

• At least a Bachelor’s degree in a scientific field.

• Background in Regulatory Operational support throughout all stages of drug development.

• Experience in managing RIM systems and Health Authority electronic platforms, such as CTIS.

• Preferred experience with VEEVA.

• Experience in supporting oncology drug development programs from a Regulatory Operations standpoint.

• Proven ability to collaborate with various key stakeholders, including external CROs.

• Capability to manage multiple, competing priorities.

• Excellent verbal and written communication abilities.

• Highly driven and resourceful.

• Proficient in setting goals, adjusting priorities, working autonomously, and collaborating effectively within project teams.

• Strong organizational skills with a keen attention to detail.

🏝️ Benefits

• Competitive base salary in the biotech sector.

• Annual target bonus (eligibility depends on company performance).

• Stock options for new hires.

• Comprehensive Medical, Dental, and Vision benefits starting from the first day of employment.

• 401(k) plan with company matching.

• Paid time off and company holidays, including a year-end company-wide shutdown.

• Paid Parental Leave.

• Life and Disability Insurance.

• Tax-advantaged health savings and spending accounts.

• Flexible work environment.

• A hands-on, collaborative workplace culture.

• Purpose-driven work that prioritizes patient care.