Senior Regulatory Submission Project Management Specialist

This individual will be responsible for supporting document management of Clinical Trial Applications (CTA) and related health authority submissions through collaborations with internal and external key stakeholders: including Chemistry Manufacturing and Controls (CMC) team members and Contract Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members.

In this role, a typical day might include:

• Responsible for supporting the tracking of Reference Safety Information (RSI) approvals by global health authorities, and tracking for Global Pharmacovigilance (PV) Planning Team. Additional responsibilities may include other documentation management needs for U.S. and other health authority submission activities.

• Responsible for tracking Clinical Trial Application (CTA) submission deliverables 

• Manage CTA regulatory submission/document transfers between Regeneron and CROs. This can include scheduling meetings (Microsoft Teams) and applicable follow-up communication for deliverables.

• Downloading of CTA deliverables from numerous CRO web-based systems and communicating updates to key stakeholders in a timely fashion. Uploading will also include numerous tracking platforms to help obtain metrics and communicate study updates to other teams. 

• Collect, upload and manage Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within the Veeva Vault RIM document repository. 

• Brief review of regulatory packages and tracking of any issues or gaps in data collection.

• Collaborates with the functional area team and key stakeholders

• Communicates key RSPM related information to consumers, collects feedback, and takes action

• Identifies and communicates regulatory system enhancement needs or technical issues

This role might be for you if can/have:

• Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).

• Knowledge and practical experience in managing global Clinical Trial Applications (e.g. IMPD) preferred

• Knowledge of pharmaceutical drug and device development process.

• Experience in Regulatory Affairs/Operations/information preferred.

• Knowledge and practical experience with RIM technologies preferred

• Knowledge of scientific industry terminology

• Knowledge of categorization and classifying information

• Ability to manage, and/or contribute to multiple ongoing projects simultaneously

• Works well in a team-environment and can provide feedback for process or project needs.

• Excellent written and oral communication skills. Self-motivated with energy and drive to work both independently and in a team environment. Can think critically and can be flexible dependent on project needs. Strong organizational skills and ability to multi-task

• Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.

• Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills

To be considered for this opportunity, you must have minimum a Bachelors Degree with 4+ years of relevant experience.

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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 chr