Director, Regulatory Affairs
Job title: Director, Regulatory Affairs
Job location: Gaithersburg, MD
Job type: Full-time position
Reports to: Chief Operating Officer
Remedy Plan is a cancer therapeutics start-up company developing a pipeline of exciting small molecule drugs that cause cancer cells to differentiate and exhibit potent activity against leukemias and several solid tumors. Our goal is to dramatically improve the lives of cancer patients.
Remedy Plan is seeking a highly motivated, innovative, and team-oriented individual to join our company to lead the Regulatory Affairs efforts as we prepare to move our lead drug candidate from pre-clinical studies into a Phase 1 clinical trial.
The main responsibilities of the Director, Regulatory Affairs include, but are not limited to the following:
- Provide regulatory advice to management for the advancement of small molecule IND applications and clinical trial design
- Manage, prepare, and complete appropriate and timely projects, packages, documentation, submissions, and amendments to regulatory agencies
- Provide regulatory input to technical/CMC and clinical content procedures to ensure they meet and maintain FDA and international regulatory compliance
- Coordinate with FDA and prepare for FDA meetings as required, including the preparation of responses and questions to be submitted to the agency
- Keep up to date on regulatory procedures and changes to submission process
- Identify and implement a system to facilitate internal tracking of all materials pertaining to regulatory affairs and clinical trials
- Assist in the establishment of strategies for drug candidates at different stages of development (e.g. preclinical development and clinical research)
- Represent the company in front of external stakeholders as necessary
- 3-5 years of regulatory experience in pharmaceutical industry
- Demonstrated track record of successful submission of small molecule drugs for regulatory approval, including direct experience interacting with relevant regulatory agencies
- Clinical Trial Application (CTA) experience is a plus
- Extensive knowledge and up-to-date understanding of drug development regulations and process
- Effective communication skills with ability to lead multi-disciplinary teams
- Legal authorization to work in the United States without sponsorship
How to apply: Submit your Cover Letter and CV to [email protected]. On the subject line include "Regulatory Affairs- your LAST NAME, FIRST NAME".
Remedy Plan will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, marital or parent status, protected veteran status, or disability status.