Associate Director, Regulatory Operations

🔥 56 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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ADC Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (ADCs). The company focuses on transforming the lives of those impacted by cancer through a robust ADC portfolio targeting hematology and solid tumors. Their capabilities include a validated technology platform and a growing research & development toolbox, resulting in an approved product, ZYNLONTA®, for treating diffuse large B-cell lymphoma. Founded in 2011 and based in Lausanne, Switzerland, with operations in London and New Jersey, ADC Therapeutics is committed to confronting cancer and advancing treatment paradigms.

📋 Description

• Execute regulatory submissions in the US and outside the US in collaboration with CROs • Optimize and maintain ADC Therapeutics’ Regulatory Information Management (RIM) system • Provide project management support for compilation of regulatory submissions • Act as the RIM system owner for all regulatory submissions • Serve as the ADCT responsible person for RIM vendor activities, including system upgrades and compliance, and submissions through the ESG • Serve as the responsible person for regional Health Authority RIM systems, such as CTIS, through collaboration with external CROs • Collaborate with CRO partners on global regulatory submissions • Establish and manage regulatory timelines from a project management perspective • Assist in developing and maintaining departmental processes, policies, SOPs, and associated documents • Perform other duties as assigned

🎯 Requirements

• 7+ years’ experience in a biotech/pharmaceutical research environment • 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 managing RIM systems and Health Authority electronic portals, such as CTIS • VEEVA experience preferred • Experience supporting oncology drug development programs from a Regulatory Operations perspective • Ability to collaborate with multiple key stakeholders, including external CROs • Ability to handle multiple, competing tasks • Strong verbal and written communication skills • Highly motivated and resourceful • Ability to set goals, shift priorities, work independently, and collaborate effectively with project teams • Good organizational skills and attention to detail

🏖️ Benefits

• Competitive biotech base salary • Annual target bonus (eligibility based on company performance) • New hire stock options • Medical, Dental and Vision benefits starting on the 1st day of employment • 401(k) with company match • Paid time off and company holidays, including a company-wide shutdown at the end of the year • Paid Parental Leave • Life and Disability Insurance • Tax-advantaged health savings and spending accounts • Flexible work environment • Hands-on, collaborative culture • Mission-driven work that puts patients first

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