The Regeneron Manager, Auditing is a key position in the Global Development Quality Assurance (GDQA) group.  This individual will create strategic partnerships and execute risk-based quality auditing activities across GDQA.  The Manager, GD Auditing (GVP) applies expertise in Good Pharmacovigilance (GVP) Practice and international regulations to the auditing process to independently address a variety of GVP compliance issues.

In this role, a typical day might include the following:

Scheduling, preparing, conducting, reporting and follow-up on routine and directed audits in support of the GVP discipline as directed and in accordance with Regeneron standard operating procedures and quality policies.  

Audits include internal audits and external audits conducted globally.   This role may require 30 – 40% travel (both domestic and international) 

Represent GDQA on teams, complex compliance projects and initiatives both within and across functional areas or other departments, as applicable. 

Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations. 

May participate in regulatory inspections by acting as part of the control and/or inspection room team 

Assist with training/orientation/mentoring of new GDQA staff 

This role may be for you if have:

in-depth knowledge of the FDA and EU regulations along with any other regulations that may affect drug development and post-authorization safety monitoring.  This individual is expected to have an in-depth level of knowledge and experience in conducting multiple audit types (e.g., process, vendor, license partner, etc.). The primary goal for the Manager, GD Auditing (GVP), is to continue to develop and master technical auditing skills with the ability to work with minimal guidance and supervision and is considered a “go-to” person in their field.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$113,100.00 - $184,700.00