Role Overview & Key Functions:The Regulatory Science Lead is responsible for advancing and applying regulatory science to all our regulatory deliverables. The incumbent will leverage his/her scientific acumen and understanding of regulatory requirements to support the Regulatory Leads and partner with cross-functional Subject Matter Experts to optimize our regulatory approach.
Key Responsibilities- Support the Regulatory Lead(s) to ensure the most advanced regulatory science is applied optimally to our regulatory strategies and deliverables across Karyopharm's development programs, as assigned
- Working under the direction of the Regulatory Leads and in collaboration with cross-functional Subject Matter Experts and Medical Writing, provide leadership in key regulatory submissions including INDs and Amendments, Meeting Packages, and Marketing Applications as well as responses to Health Authority Information Requests
- Partner cross-functionally with Clinical Development, Biostatistics, Translational Medicine, Clinical Pharmacology, Medical Writing, and Regulatory Affairs teams to ensure the Company's regulatory submissions are cohesive and the process is efficient
- In collaboration with cross-functional Subject Matter Experts, develop scientifically rigorous arguments supporting unmet medical need, clinical benefit, and benefit-risk assessments.
- Interpret evolving regulatory guidance, precedent approvals, and policy trends to educate internal stakeholders
Candidate Profile & Requirements:- Qualifications
- Minimum B.S. degree in life/health/technical sciences required
- Postgraduate degree in Regulatory Affairs is a plus
- Previous oncology experience highly preferred
- Minimum 10+ years of regulatory experience within the biotech or pharmaceutical industry
- Minimum of 10 years of experience preparing regulatory documents
- Thorough understanding of current FDA Guidance for Industry documents applicable to Karyopharm's development programs
- Strong background in the preparation of regulatory submissions including INDs and Amendments, Meeting Packages, and Marketing Applications as well as responses to Health Authority Information Requests
- Ability to work both independently with minimal direction to meet team goals
- Demonstrate excellent communication skills, both oral and written
- Strong interpersonal skills and the ability to work effectively with cross-functional colleagues
- Ability to perform research related to regulatory issues
- Computer literacy is required
At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $XXX K - XXX K USD.
