Regulatory Submission Project Specialist job in Boston, USA

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Publishing & Submissions

Location: United States

This vacancy has now expired. Please see similar roles below...

Regulatory Submission Project Specialist - Contract - Boston - REMOTE

Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!

Proclinical is seeking a Regulatory Submission Project Specialist for a remote contract role based in the EST USA time zone.

Primary Responsibilities:

The successful candidate will be involved in supporting the Regulatory Submission Management group by handling routine regulatory submissions, tracking deadlines, and assisting with major submissions such as INDs, CTAs, BLAs, and MAAs.

Skills & Requirements:

Strong knowledge of applicable Regulatory Agency regulations and guidelines (e.g., FDA, EMA, ICH).
Familiarity with eCTD and submission processes.
Ability to work with firm deadlines and adapt to changing priorities.
Expertise in document management.
Proficiency with VEEVA Vault, MS Office applications, Adobe Acrobat, and electronic document management systems (eDMS).
Bachelor's Degree required.

The Regulatory Submission Project Specialist's responsibilities will be:

Schedule and manage routine regulatory submissions, including IND safety reports and clinical site documentation updates.
Support the monitoring and tracking of submission processes for clinical site documentation.
Coordinate publications for submissions across all programs.
Track submission deliverables for routine and larger submissions.
Ensure the completeness of scheduled submissions and coordinate with Regulatory Operations on timing and document status.

Compensation:

$25.00 - $35.00 Per Hour

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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