Senior Regulatory Specialist

Senior Regulatory Consultant (TGA – Complementary Medicines, Medical Devices & Cosmetics)Maternity Leave Cover | Contract
About the RoleHealthReg is seeking an experienced Senior Regulatory Consultant to provide maternity leave cover for a valued member of our team. This is a part-time, contract position supporting clients across complementary medicines, medical devices, and cosmetics under TGA (Therapeutic Goods Administration) requirements.This role goes beyond traditional regulatory consulting — you will also play an active part in business development and client-facing customer service, helping to maintain and grow relationships with existing clients while supporting new business opportunities.
Key Details- Position type: Part-time, independent contractor engagement (maternity leave cover)- Length: 9 months, with possible extension- Hours: flexible hours negotiable- Location:Remote (Australia-based preferred; occasional online client meetings)
Key ResponsibilitiesRegulatory Consulting- Provide expert regulatory advice on the listing, registration, and compliance of complementary medicines under the TGA framework- Manage regulatory submissions and applications for medical devices, including classification, conformity assessment, and inclusion on the ARTG- Advise on cosmetic product compliance, including labelling, ingredient safety (AICIS), and claims substantiation- Prepare and review technical files, dossiers, and supporting evidence for regulatory submissions- Monitor and interpret changes to TGA legislation, guidelines, and standards, and advise clients on implications- Manage post-market compliance activities, including adverse event reporting, product recalls, and audits- Liaise directly with the TGA and other regulatory bodies on behalf of clients
Business Development- Identify and pursue new business opportunities within existing and prospective client bases- Support proposal development, scoping of services, and quoting for new client engagements- Represent HealthReg at industry events, webinars, and networking opportunities as required- Contribute to marketing and thought-leadership content (e.g. regulatory updates, articles, client newsletters)
Client & Customer Service- Act as a primary point of contact for a portfolio of clients, ensuring high-quality, responsive service- Manage client expectations around timelines, scope, and regulatory risk- Build and maintain strong, trust-based relationships with clients across diverse industries- Provide clear, practical guidance to clients who may have limited regulatory experience
Essential Requirements- Demonstrated experience in Australian regulatory affairs, specifically complementary medicines, medical devices, and/or cosmetics- Strong working knowledge of the *Therapeutic Goods Act 1989*, TGA guidelines, and relevant standards (e.g. AICIS for cosmetics)- Proven experience preparing and managing TGA submissions (listings, registrations, device inclusions)- Current and valid professional indemnity insurance and public liability insurance** (mandatory for this contract role)- Ability to operate as an independent contractor, with own ABN- Excellent written and verbal communication skills, with the ability to explain complex regulatory matters clearly to clients- Strong business development acumen and comfort with client-facing sales conversations- High level of organisation and ability to manage multiple client engagements concurrently- Availability to commence by [insert start date] for a comprehensive handover period
Desirable*International regulatory market experience highly desired— e.g. familiarity with regulatory frameworks in New Zealand, the EU, UK, US (FDA), or ASEAN markets for complementary medicines, devices, or cosmetics, and experience supporting clients with export/international registration pathways- Prior consulting or client services experience (agency, professional services, or similar)- Existing networks within the complementary medicine, device, or cosmetics industries- Experience with quality management systems (e.g. ISO 13485) an advantage
How to ApplyPlease submit your resume along with a brief cover letter outlining your relevant regulatory experience essential requirements of role, your current insurance status, and your availability