Senior Director, Regulatory Science Lead

Karyopharm Therapeutics•Newton, MA

11d

About The Position

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.

Requirements

Minimum B.S. degree in life/health/technical sciences required
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

Nice To Haves

Postgraduate degree in Regulatory Affairs is a plus
Previous oncology experience highly preferred

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