Sr Specialist, Regulatory Process & Systems Management

A Senior Specialist, Regulatory Process & Systems Management is responsible for supporting the business processes to support submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

A typical day might include the following:

• Supports development of procedure documents, or standard methodologies for RIM

• Supports system validation activities by developing and implementing test scripts for systems that support RIM processes

• Assists with identifying RIM‑related user requirements and use cases (in collaboration with cross-functional partners)

• Assists with supervising and tracking new functionality (inclusive of improvement requests) with each new release of RIM technology solutions

• Assists with providing insight into new regulations, requirements, mentorship, and/or specifications relevant to RIM technology

This role may be for you if:

• You have experience working with the VEEVA Vault RIMS System

• You understand the need for SOPs, Procedure Documents, and SOPs

• You aren't afraid to ask questions

To be considered for this opportunity, you must have a minimum of a Bachelor's Degree with 2+ years of related experience. Shown experience with Regulatory Affairs / RIMS is preferred. Other ideal experiences would include Regulatory Operations and publishing. This is a hybrid role at any of our Regeneron Office locations, with a requirement of 2-days on site and 3-days working from home.

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)

$79,000.00 - $129,000.00