Regulatory Affairs Associate

2 days ago


Sydney, New South Wales, Australia EPHealthcare Full time

Regulatory Affairs Associate – Fixed-Term Contract until the end of June 2026.

Join a leading pharmaceutical company shaping the future of aesthetics

About the Company

Our client is a global pharmaceutical leader in the aesthetic injectable market, known for delivering science-driven innovation and high-quality products that empower both healthcare professionals and patients. With a culture that values collaboration, agility, and continuous learning, this organisation offers an inspiring environment where you can make a real impact. They have a portfolio of injectable prescription aesthetic products and medical devices.

About the Role

An exciting opportunity has arisen for a
Regulatory Affairs Associate
to join the Australian team on a
fixed-term contract until June 2026 (hopefully with a view to a permanent position once headcount is approved)
. Reporting to the Regulatory Affairs Manager, you will play a key role in ensuring compliance with regulatory requirements and supporting product registrations and lifecycle management activities across the aesthetic injectable and capital equipment portfolio.

Key Responsibilities

  • Prepare, submit, and maintain regulatory documentation for product registrations, variations, and renewals in accordance with TGA requirements.
  • Support local implementation of global regulatory strategies and processes.
  • Maintain up-to-date knowledge of regulatory guidelines relevant to prescription medicines and aesthetic injectables.
  • Liaise with cross-functional teams, including Quality, Medical, PV, Regulatory and Marketing to ensure compliance throughout the product lifecycle.
  • Develop and maintain excellent working relationships
  • with relevant regulatory bodies and government
  • departments.
  • Assist in reviewing promotional materials and ensuring adherence to local regulatory and corporate standards.
  • Support the pharmacovigilance activities within the business, including PCQ and AE

About You:
You are a detail-oriented and proactive professional who thrives in a dynamic and collaborative environment. You bring a strong understanding of regulatory frameworks and a passion for contributing to the success of a fast-paced, science-led organisation.

To be successful in this role, you will have:

  • A tertiary qualification B.Science, B. Pharm, B.Eng (Biomed)
  • 1–3 years' experience in Regulatory Affairs within the pharmaceutical, medical device, or related industry.
  • At least Medical Device Conformity Assessment experience with Class III devices is required.
  • Prescription medicine experience an advantage.
  • Working knowledge of TGA regulations and regulatory submissions.
  • Excellent written and verbal communication skills with strong attention to detail.
  • Experience with Pharmacovigilance/Medicovigilance and Quality activities an advantage
  • The ability to manage multiple priorities and meet deadlines.
  • Be a collaborative, agile team player

Why Join?

  • Work with an industry leader in the fast-growing aesthetics market.
  • Collaborate with a high-performing and supportive team.
  • Gain valuable experience in a global organisation with a strong reputation for innovation.
  • Enjoy a flexible, inclusive, and development-focused culture.
  • Competitive package including health allowance

How to Apply
If you are looking to build your regulatory career within a leading pharmaceutical company and make an impact in the aesthetics space, we'd love to hear from you.

Click
Apply Now
to submit your application.

Alternatively, call John Evans on or Maryann Bastac for a confidential discussion.

Please follow us on our LINKEDIN page; EPHealthcare

Why work with EPHealthcare?

Specialists in recruitment in Pharmaceutical and Medical Devices

Outstanding network of clients

Thorough knowledge of the Healthcare industry

Industry experience - as reps, managers, marketers

Personalised and experienced approach, every step of the interviewing process.

This opportunity is only open to candidates who are eligible to work in Australia and hold the appropriate visa to work permanently



  • Sydney, New South Wales, Australia Novo Nordisk, Inc. Full time $80,000 - $120,000 per year

    Regulatory Affairs AssociateCategory: Reg Affairs & Safety PharmacovigilanceLocation:North Sydney, New South Wales, AURegulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, AustraliaAre you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive in a dynamic and...


  • Sydney, New South Wales, Australia Viatris Full time $60,000 - $100,000 per year

    Upjohn Australia Pty Ltd.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of...


  • Sydney, New South Wales, Australia Australian Prudential Regulation Authority (APRA) Full time $120,000 - $180,000 per year

    The roleAs an Advisor, Regulatory Affairs, you will lead engagement across APRA to ensure our external regulatory relationships are supported by relevant subject matter expertise. You will work on a broad range of diverse issues that are important to Australia's financial system.The teamAPRA's Regulatory Affairs team sits within the Chief of Staff and...


  • Sydney, New South Wales, Australia Lundbeck Full time $120,000 - $180,000 per year

    Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory submissions, maintaining licences and liaising with...


  • Sydney, New South Wales, Australia i-Pharm Consulting Australia Pty Ltd Full time $90,000 - $120,000 per year

    Are you a Regulatory Affairs professional ready to step into a lead role within a global, innovation-driven medical device company?This is a fantastic opportunity to join a well-established business recognised for its strong culture and high-quality products used in healthcare settings worldwide.In this role, you'll take the lead on regulatory activities...


  • Sydney, New South Wales, Australia Heng & Hurst Full time

    We're proud to partner with a global medical technology company on an ambitious journey to become one of the world's leading device manufacturers. Their diverse product portfolio features trusted, high-quality brands that are well-established in hospitals and healthcare settings.Headquartered in Sydney and backed by a strong international network, the...


  • Sydney, New South Wales, Australia Resmed Full time $120,000 - $180,000 per year

    About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories. The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.As an individual...


  • Sydney, New South Wales, Australia Resmed Full time $120,000 - $180,000 per year

    Job SummaryThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory...


  • Sydney, New South Wales, Australia Medtronic Full time $80,000 - $120,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic...


  • Sydney, New South Wales, Australia Heng & Hurst Full time $120,000 - $180,000 per year

    We're proud to partner with a global medical technology company on an ambitious journey to become one of the world's leading device manufacturers. Their diverse product portfolio features trusted, high-quality brands that are well-established in hospitals and healthcare settings. Headquartered in Sydney and backed by a strong international network, the...