[Remote] Regulatory Operations Coordinator

Note: The job is a remote job and is open to candidates in USA. Inizio Evoke is a global healthcare platform that aims to make health more human™. The Regulatory Operations Coordinator supports the department by managing brand deadlines, advising teams on submission strategies, and collaborating with other coordinators to handle large volumes of work.

Responsibilities

• 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

Skills

• 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

• Fully remote work environment
• Outstanding company-paid benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off

Company Overview