Regulatory Support Specialist

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000
Regulatory Support Specialist

The Regulatory Support Specialist is responsible for providing regulatory support to international country and/or cluster teams.

  • Supports various regulatory activities, including:
  1. M1 dossier components (local document authoring and/or coordination)
  2. Simple local-only HA query responses
  3. Providing support for cross-functional activities related to tenders, out-of-stock reporting, product reviews, risk plans, and launch coordination

This role acts as the initial point of contact for the assigned country/cluster under their responsibility, liaising with country regulatory strategists, hub submission managers/dossier managers, and other key stakeholders.

Responsibilities include but are not limited to:

  • Identification of regulatory requirements
  • Authoring, delivery, and/or coordination of local, submission-ready documents
  • Quality review/approval of the dossier provided by hub submission/dossier managers
Key Responsibilities

The Regulatory Support Specialist manages end-to-end regulatory dossiers for multiple regions, focusing on initial registration and ongoing lifecycle management until product withdrawal. The role involves engaging with functions to ensure operational efficiency and compliance.

Success is measured by timeliness, quality, compliance, and efficiency of deliverables, aiming to bring organizational efficiencies.

Depending on the region/cluster, the specialist may also serve as the Hub Submission Manager or partner closely with one.

Key Accountabilities

General accountabilities:

  • Ensure timely delivery of local M1 dossier components
  • Act as the initial contact point for the assigned cluster/country for the regulatory team and key stakeholders
  • Provide regulatory support for cross-functional activities related to tenders, out-of-stock reporting, product reviews, risk plans, and launch coordination
  • Support audit readiness activities, including audit interviews, DHPC responses, and medical info requests
  • Assist country strategists with cross-functional meetings on launch plans
  • Perform quality review/approval of dossier build tables of contents
  • Partner with growth submission managers and regional hubs to deliver growth applications and support international commercial priorities
  • Support lifecycle prioritization discussions and local document authoring for applications and variations
  • Coordinate with labeling hubs on label and artwork updates
  • Assist with simple HA query responses and coordinate with SMEs for complex queries
Requirements
  • B.S./B.Sc. in Pharmacy, Life Sciences, Business, or IT; relevant experience considered
  • Fluent English required; multilingual skills a plus
  • Proven ability to learn new software, regulations, and standards
  • Advanced MS Office skills
  • Understanding of pharmaceutical organizational structures and regulations
  • Experience in pharma regulatory, quality, or compliance fields
Working Habits
  • Self-initiating, problem-solving, able to navigate ambiguity, and recognize when escalation is needed
  • Domain expertise that drives execution and impacts business outcomes
  • Experience in matrix management and risk mitigation

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