Senior Manager Regulatory Affairs
My client is a small, collaborative biotech company focused on the development of novel immune-oncology therapies in treating patients who suffer from various forms of cancer. They have grown tremendously over the past decade. With an IPO in the near future, they are primed for taking their novel immunotherapy platform to new heights. They are currently seeking a qualified Senior Manager of Regulatory Affairs to join their dynamic, upbeat team. In this exciting new role, the Senior Manager will be managing several different programs in various stages of development.
Responsibilities:
- Help support and plan new IND submissions for first in class compound, authority interactions, partnering with FDA, submitting briefing packets on time
- A key role in supporting registration trials for our lead asset in pre-clinical development
- Be the regulatory representative with cross functional teams, fielding questions, support and conduct clinical trials
- Responsible for interactions and contact with regulatory agencies and supports formal meetings
- Collaborate with Drug Safety and CROs, to ensure timely submission of safety reports to regulatory health authorities
- Ensure regulatory activities are in compliance with regulations, health authority guidelines, and corporate policies/procedures, all within agreed upon timelines
Knowledge and Skills:
- Minimum BS in a scientific discipline; advanced degree preferred
- Minimum of five years of experience in a regulatory affairs function within the biopharmaceutical industry
- Experience with biologics drug development is preferred. Oncology/immune-oncology experience highly desirable.
- Knowledge of FDA regulations required; EU CTA requirements desirable
- Strong communication skills