Job Abstract

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

Why ADC Therapeutics

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and in the European Union. ZYNLONTA® is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients.

We consist of nearly 300 dedicated employees, all focused on patient care and driven by purpose who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!

To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on LinkedIn.

What You’ll Do:

As the Manager, Regulatory Operations and Submissions Management, this position will lead regulatory operations activities and support and manage US and global submissions for the Regulatory CMC group, part of the Technical Operations Organization. This position reports to the Senior Director, CMC Regulatory and can be a remote position and would be expected to travel as needed for business meetings to the San Francisco Bay area on a quarterly basis.

Job Responsibilities:

• Ensure creation of high-quality regulatory submissions packages aligned with health authority requirements and consistent with internal templates and style guides.
• Provide pre-publishing (technical editing and document formatting) for regulatory submissions.
• Working with Regulatory strategist and cross functional SME team, author, review, and approve regulatory submissions.
• Interface with multiple external publishing vendors to plan and manage submission activities (transfer of documents, QC output, archiving final submission documentation and receipts).
• Maintain archives of regulatory submissions and correspondence in a manner that enables quick retrieval and viewing of documentation.
• Maintain templates and style guides.
• Take initiative to address problems, identify process improvement opportunities, and drive solutions.
• Maintain awareness of changes in relevant regulatory guidance’s and technologies.

Who You Are:

• 5+ years experience in pre-publishing for regulatory submissions.
• Experience in biologics programs. Experience in antibody drug conjugates a plus.
• Advanced proficiency in MS Office applications.
• Strong knowledge of best industry practices for eCTD publishing and eCTD viewer programs/solutions.
• Proficiency using Adobe Acrobat Professional.
• Knowledge of US FDA regulatory requirements.
• Excellent organizational skills.
• Capable of managing episodic and fluid workload with tight timelines.
• Strong communication skills.
• Strong project management skills.
• Attention to detail with an ability to perform critical review of various types of documents.
• Ability to independently solve problems and facilitate resolution of issues.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• The position would require travel at a minimum of once a quarter to the San Francisco Bay Area.

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.

Attention: Search firms/Third-party recruitment agencies

The People team manages the recruiting for all positions at ADC Therapeutics. We will only accept résumés from a search agency/recruiter if we have a signed agreement in place and we have formally requested your help on a specific role. Forwarding unsolicited resumes on behalf of potential candidates and/or vendor engagement requests to ADC Therapeutics hiring managers is strictly prohibited. Unsolicited résumés sent to ADCT will be considered property of ADCT. We will not be responsible for any fees associated should we hire from unsolicited résumés. Please send all emails and requests to recruiting@adctherapeutics.com.