Regulatory Affairs
NJ, US
Worker Category: Active - Regular full-time
The Company
Now is an exciting time to join the company, a leading late stage Oncology company.
We are a company united by strong values – passion towards patients, innovation, integrity, excellence, leadership, ownership and teamwork. Our values reflect the way we strive to improve the quality of life for patients and are at the heart of our company’s success and future growth.
We continue to seek passionate, dedicated, and solutions-oriented people – and consistently ensure that our people develop their talent. If this company is to realize its vision, we need people who think innovatively and act with integrity.
We currently have an opening for Director, Regulatory Affairs in our NJ office. This role is accountable for the regulatory strategy and execution of submissions for approval by the respective country authorities. The position will report to the VP, Regulatory Affairs.
Role and Responsibilities:
- Provide overarching regulatory support for Regulatory Affairs liaising with other line function
- Responsible for finalizing and publishing submissions to the FDA (including, 7 day or 15 day expedited safety reports), EMA, Health Canada and other regulatory authorities for submitting through regulatory portal(s)
- Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities
- Coordinate responses from appropriate colleagues to regulatory agencies related to clinical study submission, drug development, launch readiness and post marketing regulatory activities as needed
- This position offers the opportunity to grow in knowledge and execution of Regulatory Affairs strategy.
Requirements:
- Bachelor’s Degree in scientific or life sciences discipline or related required.
- 7-10+ years of experience in the biopharma industry, with at least 3+ years within regulatory affairs
- Previous experience executing NDA submissions