Coordinator of Regulatory Programs

Hybrid remote in Waukesha, WI

The American Society of Gene and Cell Therapy (ASGCT) is seeking a coordinator of regulatory programs to assist with daily activities associated with ASGCT’s regulatory priorities. Primary responsibilities include providing logistical and operational support for regulatory focused programming, and the Society’s responses to relevant Food & Drug Administration (FDA) regulations. The position is hybrid and will require up to 10% of domestic travel.

Primary Responsibilities

Assist the Sr. Regulatory Affairs Manager with committee and workgroup meetings by preparing call packets, taking minutes, tracking attendance, and ensuring timely follow-up on action items as requested.
Support the Sr. Regulatory Affairs Manager in managing and processing relevant committee applications.
Coordinate scheduling, file management, and other duties as needed.
In concert with relevant departments, coordinate speaker and co-chair invitations, registrations, and session assignments for regulatory programs.
In concert with relevant departments, coordinate program updates, evaluations, and speaker reimbursements for regulatory programs.
Provide logistical support for on-site, and virtual, regulatory programs.
Maintain accurate and up-to-date tasks and deliverables in ASGCT’s project management system.
Contribute to department standard operating procedures (SOPs) within areas of responsibility.
Other duties as assigned.

Required Skills and Experience

Excellent verbal and written communication skills.
Bachelor’s Degree required; a degree in a scientific field is preferred
Attention to detail.
Strong time management, self-motivation, and interpersonal skills.
Ability to travel up to 3 weeks per year.

Salary

The annual salary for this role begins at $45,000.

About the American Society of Gene and Cell Therapy

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional organization for gene and cell therapy, with a broad membership base including scientists, clinical researchers, physicians, patient advocates, and pharmaceutical and biotechnology professionals. The mission of the Society is to advance knowledge, awareness, and education leading to the discovery and clinical application of genetic and cellular therapies to alleviate human disease. ASGCT is a 501(c)3 nonprofit organization.

Culture Statement

At ASGCT, we strive to create a collaborative environment of leaders and innovators who are committed to the Society’s mission and to the people we serve. Employees at ASGCT value these core principles:

Leadership: We are empowered to take ownership of our contributions to the organization. Fueled by a supportive leadership team, we bring integrity, expertise, and a sense of purpose to our roles.
Innovation: We think proactively and generate novel solutions to new challenges faced. Innovation drives us to be adaptable and keep pace with a rapidly evolving field.
Trust: We have established a flexible work environment where dependability and communication is what inspires success. Trust throughout the organization allows for thoughtful collaboration, transparency, and growth.

EEO Statement

ASGCT provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Type: Full-time

Pay: From $45,000.00 per year

Benefits:

401(k)
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Tuition reimbursement
Vision insurance

Schedule:

Monday to Friday

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