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 DescriptionExciting 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:
At least 7 years of Clinical Research/Regulatory/Drug Development experience.Experience with IND/NDA/BLA applications and regulatory strategy.Core Skills:
Outstanding attention to detail and strong analytical and interpersonal skills.Planning and prioritizing work to meet commitments aligned with organizational goals.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 3rd Avenue, NYCSchedule: Hybrid, with flexibility to be onsite as neededReporting to the Senior Director, Product Development and Regulatory CompliancePay Range: $98,500 - $157,600
Helpful Links:
MSK Compensation PhilosophyReview our great benefits offeringsRegulatory Oversight and Product Development at MSKLearn 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 ClosingMSK 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’s Talent Community to receive inside information on our organization and new job opportunities.