Senior Director, Regulatory Affairs

ADC Therapeutics•New Providence, NJ

2d•Hybrid

About The Position

Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives. Why ADC Therapeutics? ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States, conditional approval from the European Commission and conditional approvals in other countries. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use. We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn . What You’ll Do : This critical position is responsible for leading the preparation and maintenance of INDs, BLAs and clinical trial applications e.g CTR that are compliant with US, foreign regulatory requirements, and company standards. The incumbent will act as the regulatory lead on assigned project teams, providing regulatory leadership, guidance and oversight. Reporting to the Head of Global Regulatory Affairs, this role can be remote/hybrid. Some travel to the New Providence, NJ office will be required once a quarter or more as needed.

Requirements

15+ years’ experience in a biotech/pharmaceutical research environment, including 10+ years in Regulatory Affairs
Minimum of a Bachelor’s degree in a scientific discipline or equivalent, with PhD or Master’s degree preferred
Experience in regulatory strategic support to all phases of drug development
Experience in preparation, submission, and FDA review of INDs, BLAs or NDAs
Team player who can collaborate and work successfully with multiple key stakeholders including external CROs
Ability to successfully handle multiple, competing tasks in a fast-growing company environment
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

Nice To Haves

Experience in oncology drug development strongly preferred including, for example, immuno-oncology, hematology, ADCs and other bio-pharmaceuticals
EU regulatory experience preferred including CTR
Prior people management experience preferred

Responsibilities

Act as the primary regulatory representative on, and provide strategic regulatory guidance to, assigned project teams and sub-teams
Lead the planning and preparation of global regulatory global submissions (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions)
Management of, and collaboration with, CRO partners for regulatory submissions
Represent Regulatory Affairs with licensing partners
Establish and manage regulatory timelines
Serve as the liaison between the company and global health authorities, including FDA, for assigned projects
Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies including developing strategies for such meetings
Prepare regulatory development plans for assigned projects
Develop and maintain regulatory knowledge of US, EU and ROW regulations
Coordinate and prepare responses to Regulatory Agency requests for information
Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports)
Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents