Temp Regulatory Submission Project Management Specialist

Pay Range:  $31.82 - $37.59/hr

Remote Role (US Only)

12 Month Contract

Provide support to the Regulatory Submission Management (Reg SM) group by working on routine regulatory submissions, responsible for tracking deadlines for various regulatory obligations, and assist with submission work for major submissions such as INDs, CTAs, BLAs and supplements, MAAs and variations.

A typical day might include the following:

· Schedules and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces

· Provides support for monitoring and tracking performance of submission process for clinical site documentation (Form FDA 1572)

· Coordinates publications (literature references) for submissions across all programs

· Tracks submission deliverables for routine submissions, and provides support in tracking deliverables for larger submissions

· Manages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status

his role may be for you if have:

· Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

· eCTD knowledge.

· Experienced in submission processes and systems

· Ability to work with firm deadlines and adapt quickly to changing priorities

· Expertise in document management

· Strong knowledge with VEEVA Vault, MS Office applications, Adobe Acrobat, electronic document management systems (eDMS) required.

To be considered for this role, you must have a Bachelor’s Degree and 0-2 years of industry and/or relevant experience

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation