Regulatory Operations Coordinator

Inizio Evoke

Regulatory Operations Coordinator supporting healthcare submission processes at Inizio Evoke. Managing brand deadlines and project coordination in a fully remote role.

Posted 4/15/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $58,000 - $65,000 per yearWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Manage multiple brand deadlines as a Shared Resource
Advise teams regarding timing and recommended submission strategies
Snagging/Screenshotting
Build PDF review docs using SOPs for guidance
Transfers/copies functional and reference annotations
Write functional annotations
Maintain files/records of all stages of review
Organize submissions documents on shared server
Server maintenance/clean-up
Monitor submission mailbox for relevant notifications
Downloads MLR comment files and sends path to team
Files approvals and sends path to team
Open MLR job codes across varying client platforms
Upload or submit any new reference materials provided by copy and MedEd
Gather all documents needed for a submissions package
Set up, start, monitor and gain team approval on submission review routes
Upload and submit materials for MLR review
Links references in Submission Platform (Vault)
Prepare OPDP binders
Monitor archiving/digital asset upload process with internal team
Provide recommendations for improved submissions (i.e., formats and layouts)
Updates Project Dashboard and tracks submission dates for internal team
Update Shared Reg Ops excel sheet with upcoming and completed submissions
Attend project Kick offs and review timelines as needed by manager

Requirements

What you’ll need

Highly deadline-driven
Adaptable and flexible, able to quickly adjust to shifting timelines, priorities, and client needs
Strong multitasker who can balance concurrent projects without sacrificing accuracy or quality
Detail-oriented with a sharp eye for consistency, compliance, and completeness across submission materials
Proactive communicator who keeps teams informed and anticipates potential roadblocks
Organized and process-minded, with the ability to manage complex workflows and documentation efficiently
Comfortable working across multiple systems and platforms, with a willingness to learn new tools quickly
Collaborative team player who can also work independently and take ownership of tasks
Solutions-oriented mindset with a focus on improving processes and increasing efficiency
Ability to remain calm and focused under pressure, especially during tight deadlines and submission cycles

Benefits

Comp & perks

Inizio Evoke offers a fully remote work environment and outstanding company-paid benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SnaggingScreenshottingFunctional annotationsPDF review documentationSubmission review routesMLR job codesArchivingDigital asset uploadSubmission package preparationProject Dashboard updates

Soft Skills

Deadline-drivenAdaptableMultitaskingDetail-orientedProactive communicationOrganizedCollaborativeSolutions-orientedCalm under pressureProcess-minded