Responsibilities

  • Lead regulatory projects from initial scoping through delivery and client follow-up.
  • Manage client relationships, project resources, timelines, and deliverables.
  • Act as a regulatory subject-matter expert.
  • Support product development and regulatory strategies for medicines, biologicals, and medical devices.
  • Evaluate CMC, clinical, and non-clinical evidence supporting new registrations and lifecycle activities.
  • Review, critically evaluate, prepare, and submit regulatory documentation.
  • Review and perform quality control of regulatory, quality, and compliance documentation.
  • Support literature-based submissions, including associated overviews and summaries.
  • Assist clients with responses to regulatory authority questions.
  • Manage lifecycle maintenance activities for registrations, listings, and inclusions.
  • Prepare and submit safety-related updates to Product Information documents.
  • Deliver regulatory submissions, reports, presentations, and strategic recommendations.
  • Participate in meetings with clients and regulatory authorities.
  • Supervise, mentor, and develop members of project teams.

Requirements

  • Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.
  • Minimum 8 years of regulatory affairs experience, preferably in a commercial environment.
  • Experience reviewing, critically evaluating, and presenting data for medicine dossiers.
  • Good knowledge of regulatory legislation, guidelines, and procedures in Australia, New Zealand, and the JAPAC region.
  • Previous project-management and/or consulting experience.
  • Strong client-management, problem-solving, and communication skills.
  • Ability to manage complex and confidential information.
  • Willingness to travel when required.
  • Postgraduate qualification in a relevant discipline would be an advantage.
  • Fluent English.

Publish Date

21 August, 2026

Spontaneous Application

Regulatory Affairs Expert / Senior Consultant - VAF 645

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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