The Manager, Regulatory Intelligence will be involved in supporting the gap analysis/readiness planning for critical regulatory initiatives such as the EU CTR (Clinical Trial Regulations), EU Pharma regulation, PUDFA etc, across different functions at Regeneron. We believe the Manager will be responsible for Regulatory Intelligence activities for global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization, as well as supporting GxP focused intelligence queries from various departments within the organization.
In this role, a typical day might include the following:
- Supervise and analyze regulatory intelligence sources for the most recent changes and information in the drug development space
- Assess regulatory intelligence information for relevance and impact to company’s internal processes, drug development projects and/or regulatory strategies
- Provide regulatory intelligence in support of a range of operational study design and operational planning activities. This includes regular updates on new GxP information including non-clinical, clinical and CMC, that could impact clinical trial execution.
- Collaborate with cross-functional teams from preclinical to commercial to identify and assess key regulatory requirements, regulations, guidances, and information
- Primarily, this role will focus on support of CMC requests
- Support of requests from other Parent organization will be secondary
This role might be for you if:
- You have prior experience in CMC, Quality, Companion Diagnostics
- You bring a strong understanding of the drug development and commercialization process, with a focus on CMC, preferred experience with IVDR, EU MDR
- You understand and interpret regulatory guidelines and documents
- You are capable to research, analyze and extrapolate critical regulatory information with a focused on clinical requirements
To be considered, we look for 4+ years of life science experience with a focus in CMC Regulatory with a focus on IVD. We also expect candidates to be onsite a couple days a week as well.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)