Jobs NYC

Pay Range

$75,500.00-$116,900.00

Company Overview

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.

Job Description

Exciting opportunity at MSK: Join our team as aRegulatory Affairs Analyst! We’re looking for a dynamic clinical research professional to join our dynamic and growing team!

Role Overview:

• Assist in the daily activity of regulatory compliance and operations at MSKCC in the Investigational New Drug Office, including and not limited to Investigational New Drug (IND) Applications, Investigational Device Exemptions (IDE) , Single Patent Uses (SPUs, also known as Compassionate Use), IND/Device Committee reviews and Biotechnology Collaborations.

• Largely responsible for the submission and oversight of all dossiers from MSK to the FDA in an Electronic Common Technical document (eCTD) format and ensure that MSK is compliant and adheres to eCTD specifications.

• Prepares, reviews and analyzes all FDA submissions to ensure compliance and alignment of institutional, state, and federal regulations.

• Serves as a resource and regulatory expert, monitor federal regulatory requirements and works with leadership to communicate these regulations with investigators and research staff throughout the Institution.

• Participate in the regulatory review process for the Institutional Investigational New Drug Committee (INDDC), including conducting detailed reviews of submissions.

• Oversees and manages the FDA regulatory approval process for IND/IDE submissions, acting as a liaison between the FDA and internal collaborators and ensuring responses and reports submitted to the FDA align with institutional, state, and federal regulations.

• Respond to inquiries, addressing feedback and troubleshooting with regulatory issues.

• Maintain all databases and portals within the IND Office and supervise trends as they relate to IND submissions or regulatory metrics.

• Work on special educational projects (e.g. training manuals, newsletters, or didactic training program development) as needed.

  Key Qualifications:

• A minimum of 2-4 years of experience in Clinical Research or a Regulatory environment.

• Strong understanding of IND and IDE requirements in compliance to US 21 CFR Part 312 and US 21 CFR 812.

• Familiarity with eCTD format and submissions and FDA submission requirements. Proficiency with eCTD regulatory information management system and publishing tools is a plus.

  Core Skills:

• Outstanding attention to detail in a fast-paced environment.

• Strong analytical and interpersonal skills.

• Extensive knowledge and understanding of the regulations pertaining to human subject protection research (21 CFR 50, 21 CFR 56, 45 CFR 46), Investigational Drugs (21 CFR 312) Investigational Devices (21 CFR 812), and ICH guidelines.

• Planning and prioritizing work to meet commitments aligned with organizational goals and ability to manage multiple competing projects and deadlines simultaneously.

• Critical thinking and problem-solving to ensure unforeseen issues are handled appropriately and resolved in a timely fashion.

• Excellent communication skills and the ability to interact across all levels in a confident, professional manner.

• Enthusiasm and dedication to MSK's vision, mission and values.

  Additional Information :

• Location: 633 Third Avenue, NYC

• Schedule: Hybrid, 1-2 days per months onsite

• Reporting to the Associate Director, Regulatory Affairs

  Pay Range: $70,700.00 - $109,500.00

  Helpful Links :

• MSK Compensation Philosophy (https://careers.mskcc.org/frequently-asked-questions/)

• Review our great benefits offerings

Closing

MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Stay in touch!

Register now to join Memorial Sloan Kettering’sTalent Community (https://externaltalent-mskcc.icims.com/connect?back=intro&in_iframe=1&hashed=-435744324) to receive inside information on our organization and new job opportunities.

Job LocationsUSA-NY-New York

Posted Date2 days ago(3/21/2025 3:59 PM)

Requisition ID 2025-83953

Pay Range $75,500.00-$116,900.00