Regulatory Strategy Manager

Regulatory Strategy Manager

Job Locations USA-NY-New York

Requisition ID

2025-83321

Pay Range

98,500.00-$157,600.00

Pay Range

98,500.00-$157,600.00

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 pursueour missionat MSK and around the globe.

Job Description

Exciting opportunity at MSK : Join our Investigational Product Development and Regulatory Compliance team as a Regulatory Strategy Manager! We're looking for a dynamic Investigational New Drug regulatory professional to lead and implement the regulatory strategy, objectives, policies, and programs pertaining to the development of MSK manufactured drug products.

Role Overview :

IND Regulatory Strategy : Develop and implement strategies to obtain and maintain FDA approvals for MSK-manufactured products.

• FDA IND Designations : Author Pre-IND Packages, FDA Specialty Designations (Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease Designation applications)
• Risk Assessment : Identify and assess regulatory risks associated with product development and provide strategic guidance.
• Collaboration : Advise MSK investigators, biotechnology collaborators, Core Facility scientists, and clinical research staff on investigational drug, device, and biologic regulations.
• Regulatory Compliance & Expertise : Maintain advanced knowledge of OHRP, FDA, NIH / NCI regulations and state / institutional policies, ensuring adherence to current standards.
• Data-Driven Decision Making : Capture and analyze regulatory data to inform actionable regulatory strategies and advise stakeholders on FDA trends and updates.
• Regulatory Tracking & Reporting : Monitor IND regulatory activities, track key metrics, and ensure timely and accurate reporting to regulatory bodies.

Key Qualifications :

Core Skills :

Additional Information :

Avenue, NYC

Pay Range : $98,500 - $157,600

Helpful Links :

Learn more about Investigational Product Development and Regulatory Compliance team :

As part of Regulatory and Product Development Unit within MSK's Clinical Research Administration (CRA), the regulatory team is responsible for ensuring that investigators and clinical research staff adheres to institutional standards and federal regulatory requirements set forth by the FDA, NIH and OHRP regarding investigational drugs, devices, and biologics for all MSK sponsored IND trials and MSK manufactured products. The team oversees the management of MSK's Investigational New Drug and Device (IND / IDE) Program and provide expert guidance to MSK investigators on regulatory and product development strategy for MSK's IND / IDE studies including the preparation of IND applications / technical documents for regulatory agencies.

LI-Hybrid

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.

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Salary : $98,500 - $157,600