Associate Director, Regulatory Operations (U.S. Remote)

ADC Therapeutics America Inc; New Providence (NJ); Remoto; USD 150.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus potential

Medical, Dental, Vision benefits

401(k) with match

Paid time off and holidays

Stock options

Descrizione del lavoro

ADC Therapeutics is seeking an Associate Director of Regulatory Operations (Remote) to lead regulatory submissions in the US and internationally, in collaboration with CROs. This hand-on role also maintains the RIM system and supports project management for regulatory submissions.

The position reports to the Head of Global Regulatory Affairs and may require some travel to the New Providence, NJ office. A strong background in Regulatory Operations and oncology drug development is preferred.

Competenze

• 7+ years in biotech/pharma research, incl. 5+ years in Regulatory Affairs Operations.
• Bachelor’s degree in a scientific discipline.
• Regulatory Operations support across all drug development phases.
• Experience managing RIM systems and HA electronic portals (CTIS).
• Experience supporting oncology drug development from Regulatory Operations.
• Team player with external CRO collaboration.
• Strong organizational and multitasking abilities.
• Excellent verbal and written communication skills.

Mansioni

• Hands-on tactical execution of Regulatory related systems.
• Act as Regulatory Information Management system owner for submissions.
• US: responsible person for RIM vendor interactions and ESG submissions.
• Non-US: responsible person for regional HA portals with CROs.
• Collaborate with CRO partners for global regulatory submissions.
• Establish and manage regulatory timelines from a PM perspective.
• Develop and maintain departmental processes, SOPs and documents.
• Other duties as assigned.

Conoscenze

Regulatory Operations

RIM systems

CTIS

Veeva

Oncology regulatory

Stakeholder collaboration

Multitasking

Communication skills

Formazione

Bachelor's degree in science

Strumenti

Veeva

CTIS

Descrizione del lavoro

All Jobs > Associate Director, Regulatory Operations (Remote)

Associate Director, Regulatory Operations (Remote)
Fully Remote • Remote Worker/Hybrid - US (non-field) • Regulatory Affairs

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 and conditional approval from the European Commission. 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 150 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 .

Summary:

This critical position is responsible for the execution of regulatory submissions in both the US and outside of the US (in collaboration with CROs) and further optimizing and maintaining ADC Therapeutics RIM system in addition to providing project management support for compilation of regulatory submissions. Reporting to the Head of Global Regulatory Affairs, this role can be remote. Some travel to the New Providence, NJ office as needed.

What You’ll Do:

• This role is an individual contributor responsible for the hands-on tactical execution of our Regulatory related systems.
• Act as the Regulatory Information Management (RIM) system owner with associated tasks linked to this function for all regulatory submissions:
• US: Act as the ADCT responsible person for all activities with the RIM vendor (system upgrades, compliance etc) and submissions through the ESG.
• Non-US: Act as the responsible person for regional Health Authority RIM systems on behalf of ADCT (eg CTIS) through collaboration with external CROs.
• Collaborate with CRO partners for global regulatory submissions
• Establish and manage regulatory timelines from a project management perspective
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
• Other duties as assigned

Requirements

Who You Are:

• 7+ years’ experience in a biotech/pharmaceutical research environment, including 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 in management of RIM systems, and HA electronic portals (eg CTIS), VEEVA experience preferred.
• 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
• 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

What We Offer:

• Competitive biotech base salary, annual target bonus (eligibility based on company performance) or quarterly IC (field sales roles) and new hire stock options – so you share in the value you help create
• Medical, Dental and Vision benefits which start on the 1st day of employment
• 401(k) with company match
• Paid time off and company holidays including a company wide shut down at the end of the year
• Paid Parental Leave, Life and Disability Insurance, Tax advantaged health savings and spending accounts
• A hands-on, collaborative culture with other passionate biotech professionals
• Mission-driven work that puts patients first

Join Our Inclusive Team:

ADC Therapeutics is an equal opportunity employer. We are committed to building collaborative, engaged teams and fostering a professional and respectful work environment where employees are empowered for success. We consider all qualified applicants without regard to any characteristic protected by law.