Regulatory Operations Coordinator

ComplianceComplianceFull TimeRemoteSeniorTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

65 days ago

Salary

$58K - $65K / year

Seniority

Senior

Associate DegreeEnglishVault

Job Description

Regulatory Operations Coordinator

Inizio Evoke

• 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

Job Requirements

  • 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

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

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Convatec logo

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