Temp - Regulatory Submission Project Management

Pay Rage: $332.69 - $40.40/hr

Remote Role (US Only)

12 Month Contract

The Temp Regulatory Submission Project Management will 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 may include:

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

This role could be for you if you have:

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

experience with eCTD knowledge.

Experience in submission processes and systems

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

Expertise in document management

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

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