About the Opportunity
Our client is a commercial-stage oncology company seeking a FDA Regulatory Associate to support the VP, Lead Regulatory Counsel in providing the business with strategic advice on regulatory issues. This is a great opportunity to lead a team that is working towards developing a novel, proprietary therapy for the treatment of solid tumor cancers. The role requires high performers who thrive in fast-paced environments and are inspired by making a difference in cancer care.
The annual base salary range is $150,000 to $170,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Be an integral member of the Lead Regulatory Counsel’s team, which is broadly responsible for providing the business with strategic advice and counsel on regulatory issues and providing the Global Regulatory Affairs function with US FDA regulatory expertise in support of obtaining and maintaining regulatory approvals
- Under the direction of the Lead Regulatory Counsel, liaise with other business functions as needed (Clinical, Medical Affairs, Quality Assurance, Clinical Operations, Marketing) to provide regulatory affairs and regulatory sciences guidance throughout the product development cycle
- Hands on drafting and review of US FDA filings for the company’s commercial devices and investigational devices under clinical study, including pre-submissions and postmarket approval reports
- Provide regulatory-based scientific and statistical input in the planning and design of clinical studies (including feasibility studies), premarket clinical studies and postmarket studies in support of US FDA marketing applications
- Help facilitate cross-functional team inputs for regulatory submissions
- Support the Lead Regulatory Counsel in the assessment of regulatory pathways for new products and product modifications
- Remain current on regulatory issues/trends affecting the business, assessing and communicating their impact to colleagues, product development/support teams, and to others in the business
- Under the direction of the Lead Regulatory Counsel, assist in the creation or updating of regulatory standard operating procedures, work instructions, and policies to ensure compliance with regulatory and clinical study-related activities
Job Requirements
- Advanced degree in Lifesciences, Health Technology, Law or Engineering
- Minimum of 5-7 years of Regulatory experience
- Experience with submissions to FDA of premarket and postmarket regulatory submissions
