Director, Regulatory Affairs Operations

Description:

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 further developing and strategically optimizing global Regulatory submissions leading the preparation and maintenance of INDs, BLAs and clinical trial applications (including CTR), including developing systems for submissions through the FDA electronic gateway. The incumbent may also act as the regulatory lead on assigned project teams if needed. 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.

Job Responsibilities:

Act as the Regulatory Information Management (RIM) system owner with associated tasks linked to this function for all regulatory submissions (US and ex-US), and ultimately be accountable for establishing the RIM system to submit regulatory filings through the FDA ESG gateway. Also acts as the ADCT responsible person for all activities with the RIM vendor (system upgrades, compliance etc) Act as the "responsible person" for regional HA systems on behalf of ADCT (eg CTIS) while collaborating with external CROs In collaboration with the Regulatory Lead, plan and prepare global regulatory submissions from a Regulatory Operations perspective (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions etc) Collaborate with CRO partners for global regulatory submissions Establish and manage regulatory timelines In collaboration with program Regulatory lead, prepare meeting requests and briefing documents, 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 and electronic submissions Maintain active INDs/CTAs/CTRs/BLAs (amendments and annual reports) from an operational perspective Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents

Requirements:

Who You Are :

10+ years' experience in a biotech/pharmaceutical research environment, including 7+ years in Regulatory Affairs Operations Minimum of a Bachelor's degree in a scientific discipline or equivalent, with PhD or Master's degree preferred Experience in Regulatory Operational support to all phases of drug development Experience in the preparation, submission, of INDs, BLAs or NDAs in the US and CTR/CTA outside of the US Experience in implementation and management of RIM systems, and HA electronic portals (eg CTIS) Experience in supporting oncology drug development programs from a Regulatory Operations perspective 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 Join Our Inclusive Team 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. Director, Regulatory Affairs Operations New Providence, NJ Hybrid work

Description:

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 further developing and strategically optimizing global Regulatory submissions leading the preparation and maintenance of INDs, BLAs and clinical trial applications (including CTR), including developing systems for submissions through the FDA electronic gateway. The incumbent may also act as the regulatory lead on assigned project teams if needed. 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.

Job Responsibilities:

Act as the Regulatory Information Management (RIM) system owner with associated tasks linked to this function for all regulatory submissions (US and ex-US), and ultimately be accountable for establishing the RIM system to submit regulatory filings through the FDA ESG gateway. Also acts as the ADCT responsible person for all activities with the RIM vendor (system upgrades, compliance etc) Act as the "responsible person" for regional HA systems on behalf of ADCT (eg CTIS) while collaborating with external CROs In collaboration with the Regulatory Lead, plan and prepare global regulatory submissions from a Regulatory Operations perspective (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions etc) Collaborate with CRO partners for global regulatory submissions Establish and manage regulatory timelines In collaboration with program Regulatory lead, prepare meeting requests and briefing documents, 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 and electronic submissions Maintain active INDs/CTAs/CTRs/BLAs (amendments and annual reports) from an operational perspective Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents

Requirements:

Who You Are :

10+ years' experience in a biotech/pharmaceutical research environment, including 7+ years in Regulatory Affairs Operations Minimum of a Bachelor's degree in a scientific discipline or equivalent, with PhD or Master's degree preferred Experience in Regulatory Operational support to all phases of drug development Experience in the preparation, submission, of INDs, BLAs or NDAs in the US and CTR/CTA outside of the US Experience in implementation and management of RIM systems, and HA electronic portals (eg CTIS) Experience in supporting oncology drug development programs from a Regulatory Operations perspective 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 Join Our Inclusive Team 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.