Regulatory Affairs Manager

About the role

At Evaris Pharma, we are committed to evolving medicines. As a growing pharmaceutical company, we take pride in our innovation, integrity and impact on patient care. We manufacture and distribute high-quality, trusted therapeutic solutions that help support healthcare professionals to effectively prevent or treat a range of medical conditions.

Our Scientific Affairs team is looking for an experienced Regulatory Affairs Manager to join our team. As Regulatory Affairs Manager, you will lead and manage regulatory activities across our medicines and medical devices portfolio, ensuring compliance with applicable regulations throughout the product lifecycle, from development and registration through to ongoing product maintenance. You will act as a key point of contact with regulatory authorities and work cross-functionally with R&D, Commercial, Quality and Operations teams as well as managing external regulatory consultants during periods of peak demand. This is a hands-on role developing and supporting a small team and completing regulatory work yourself.

This is a full-time position with hybrid working available, combining time in our Perth office with flexibility to work remotely 2 days per week. Preferably the position will be in Perth, however consideration will be given to outstanding candidates in other cities who have demonstrated the ability to work effectively remotely. Part-time applicants who are a good fit with the role and have demonstrated the ability to be effective on a part-time basis will also be considered.

Key Responsibilities

• Develop and execute regulatory strategies for new and existing medicines and medical devices
• Prepare, submit, and manage regulatory applications for new product authorisations and variations
• Liaise with Australian and New Zealand regulatory authorities
• Monitor and interpret evolving regulatory requirements for both pharmaceuticals and medical devices, advising internal stakeholders on the impact of changes and how to achieve optimal outcomes for patients and other stakeholders
• Collaborate with R&D, Commercial, Quality Assurance and Operations teams on regulatory input throughout product development
• Manage relationships with external regulatory consultants, in-licence and export business partners
• Provide regulatory guidance and training to internal stakeholders
• Maintain regulatory documentation and ensure audit-readiness

Skills & Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field
• Over 10 years’ experience in regulatory affairs within the pharmaceutical and/or medical device industry with proven ability to deliver challenging projects on time and on budget
• Over 10 years’ experience managing people and a portfolio of products
• Ability to develop pragmatic and innovative regulatory strategies to achieve product approval with optimal claims in the most efficient way
• Solid understanding of relevant regulatory frameworks
• Experience preparing and managing regulatory submissions and interacting with authorities
• Strong attention to detail and excellent organisational and project management skills
• Ability to work independently and manage priorities
• Persuasive communication skills, both written and verbal, with the ability to work cross-functionally
• Ability to develop others in Regulatory Affairs and function as subject matter expert

If you are interested in the above opportunity, please submit a covering letter and resume that best demonstrates your ability to meet the requirements of the role as outlined in the information provided no later than close of business on 26th August 2026. Assessment of candidates will be performed as applications are received so early applications are encouraged.