TMF Manager

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. We are looking for a TMF Manager, you’ll play a critical role in maintaining inspection-ready Trial Master Files (TMFs) that support groundbreaking therapeutic advancements. Reporting to the Head of TMF Operations, this remote role offers the chance to collaborate globally, drive quality, and make a meaningful impact. This is a temporary 6 months role.

In this role, you will:

• Lead TMF Health initiatives to ensure accuracy and completeness.

• Collaborate with CROs and internal teams to resolve documentation issues.

• Present eTMF updates at study-related meetings.

• Develop and maintain TMF plans and inventories.

• Conduct reviews to confirm inspection readiness.

• Communicate metrics and compliance updates to stakeholders.

• Manage process improvement projects within the TMF organization.

• You are detail-oriented and thrive in dynamic environments.

• You enjoy collaborating with diverse teams and stakeholders.

• You have expertise in the TMF Reference Model and eTMF systems.

• You are proficient in Microsoft tools like Word, Excel, and PowerPoint.

• You are proactive, adaptable, and solution-focused.

Applicants must hold a Bachelor’s degree or equivalent, with at least 5 years of relevant experience. Familiarity with TMF Reference Model and eTMF systems is essential. Strong communication and organizational skills are required, along with proficiency in Microsoft applications.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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.