ABOUT EASTERN PHARMACEUTICAL GROUP

Eastern Pharmaceutical Group is an Australian pharmaceutical and nutraceutical business supporting product development, regulatory compliance and manufacturing for brand owners. Our work spans TGA-listed complementary medicines and FSANZ-regulated dietary supplements and sports foods, including capsules, powders, liquid, gummies and other dosage formats.

We are strengthening our internal regulatory function and are looking for someone who wants practical responsibility, varied projects and a long-term career with a growing Australian business.

ABOUT THE ROLE

We are seeking a Regulatory Affairs Officer or Regulatory Affairs Associate to join our Castle Hill office on a permanent part-time basis, working 3-4 days per week. This is a fully on-site, hands-on role covering product classification, formulation assessment, TGA listings, evidence, labels, artwork, claims and regulatory records.

We welcome applicants with direct regulatory experience as well as passionate early-career candidates with a relevant qualification, robust foundational knowledge and exceptional attention to detail. Training and mentoring will be provided to the right person.

KEY RESPONSIBILITIES

· Assess proposed products and determine whether they should be regulated under the TGA or FSANZ framework, including the appropriate pathway and compliance requirements.

· Review complementary medicine formulations against the current Therapeutic Goods Permissible Ingredients Determination, including ingredient names, active or excipient status, quantities, routes, restrictions, mandatory warnings and label statements.

· Review proposed indications against the current Permissible Indications Determination, assess supporting evidence, and prepare or maintain AUST L listings and variations through TGA Business Services.

· Draft and review TGA and FSANZ labels and artwork, including ingredients, directions, warnings, allergen declarations, nutrition information panels, claims,



sponsor or supplier details, country of origin, batch and expiry information, and consistency with specifications and ARTG records.

· Maintain regulatory dossiers, evidence packages, project trackers, change-control records and approved artwork; monitor regulatory changes and support responses to TGA, customer, supplier and manufacturer enquiries.

SKILLS AND EXPERIENCE

· A relevant qualification in pharmacy, pharmaceutical science, chemistry, biomedical science, biotechnology, food science, food technology, nutrition or related discipline.

· Knowledge of Australian complementary medicine and/or food regulation, including the Australian Regulatory Guidelines for Listed Medicines, TGA permissible ingredients and indications, TGAC and the Australia New Zealand Food Standards Code.

· Experience with TGA Business Services, AUST L applications, evidence review, product specifications, or TGA and FSANZ label assessment is highly regarded but not essential for a strong development candidate.

· Strong regulatory research, technical writing, organization and document-control skills, with excellent working knowledge of Microsoft Word and Excel and exceptional attention to detail.

· Ability to manage several projects and deadlines, communicate professionally, work collaboratively and attend our Castle Hill office 3-4 days each week. Full Australian working rights are required.

WHAT WE OFFER AND HOW TO APPLY

This permanent part-time role offers $30-$40 per hour plus superannuation, depending on capability and experience. You will receive practical exposure to a broad range of products, direct involvement in product development and launches, and training and mentoring where required. There is genuine opportunity to grow with the company and help build our internal regulatory systems.

Please apply with your CV and a short cover letter outlining your TGA and/or FSANZ experience, relevant qualifications, days of availability, remuneration expectations and interest in complementary medicine regulatory affairs.

📌 complementary medicine regulatory officer (Castle Hill)
🏢 Eastern Pharmaceutical Group
📍 Castle Hill