Director, Regulatory Affairs / CMC
A key leadership position in the therapeutic area of Oncology.
Responsibilities include all development activities, marketed products, including CMC, labeling changes, and regulatory compliance of marketed products.
Position requires a leader who can generate and effectively implement all strategic initiatives and programs, and communicate the status of all work to leadership and Board of Directors.
The position is global in scope and will require the management of all global marketed products.
1. Provide strategic leadership on all regulatory activities in support of any drug development work
2. Contribute to the design and implementation of competitive regulatory strategies
3. Write IND, NDA submissions for oncology drug products
4. Represent Regulatory Affairs in strategic meetings and provide regulatory guidance to project teams.
5. Interface and coordinate with FDA and other regulatory agencies on submissions, approvals or other issues. Attend and lead regulatory agency meetings and teleconferences.
6. Responsible for review and/or management of all regulatory activities, including: Annual Reports, drug safety updates, post-approval manufacturing changes, stability updates; review submission packages, labeling revisions, or promotional materials for compliance with global regulations
7. Maintain up-to-date knowledge on international and domestic regulatory requirements including all drug development and marketed support requirements.
Education required/ preferred: Advanced degree required; MD, PhD or PharmD preferred; background in medicine, pharmacy, biology or other life science required.
15+ years in a senior leadership position within Regulatory Affairs