Regulatory Affairs Specialist

5 days ago

Melbourne, Victoria, Australia Aesop Full time
Regulatory Affairs Coordinator

Aesop is seeking a detail-oriented and organized Regulatory Affairs Coordinator to join our team on a full-time basis, working in a hybrid pattern from our global head office in Collingwood.

This role will support the Regional Regulatory Affairs teams throughout the product lifecycle, from pre-market concept to post-market advertising compliance and vigilance activities.

Key Responsibilities:
  • Conduct regulatory reviews for formulation/product name and New Product Category
  • Prepare and dispatch documentation for product registration
  • Register products according to regulatory requirements
  • Update registration database and advise stakeholders on registration progress
  • Create and maintain efficacy reports/Tables of Evidence to support product claims
  • Coordinate registration updates for reformulations, acting as the main point of contact to the Product Project Manager
  • Develop and maintain Product Information Files (PIFs), ensuring company confidentiality and IP is protected
  • Research compliance requirements for new markets as needed
  • Review and approve product artwork and marketing advertising copy according to regional regulatory requirements
  • Stay up-to-date with regulatory changes in our markets, assessing and communicating impact to Aesop
  • Support risk identification, reduction, mitigation, and escalation processes
  • Compile and procure notarized documentation, such as Certificates of Free Sale and Product Safety Assessments as required for product registration
Requirements:
  • Demonstrated experience interpreting TGA listed medicines/therapeutic goods Act and Regulations
  • Cosmetics regulatory experience is highly regarded
  • Developed experience in regulatory artwork copy briefing and proofing
  • Strong communication and presentation skills
  • Ability to navigate ambiguity and manage stakeholders in fast-paced environments
  • Critical thinking and attention to detail
  • Strong time management and organizational skills
What We Offer:
  • Flexible working arrangements
  • Flexible Fridays (summer hours)
  • Generous product discount and complimentary product allocation
  • Team lunches, sponsored social clubs, team events, and celebrations
  • Parental leave and vaccination leave
  • Individual training budget and access to LinkedIn training library suite
  • Home office set-up reimbursements
  • Short-term incentive bonus programs
  • Access to Employee Assistance Program and wellbeing offerings

Aesop is committed to promoting inclusion for all and believes that diversity, inclusion, and belonging play an important role in our success. We actively encourage everyone to consider becoming a part of our journey.

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