[ref. v71693220] Manila - Regulatory Affairs Associate (Pharma) - Work From Home

• Develop, review, and coordinate product labels (including updates and new product developments) in accordance with Therapeutic Goods Order No. 92 (TGO 92) and other applicable TGOs.
• Review and compile Evidence Packages and Evidence Tables to support product listings.
• Prepare, lodge, and maintain Listed Medicine applications on the Australian Register of Therapeutic Goods (ARTG).
• Ensure ongoing regulatory compliance of marketed products, including post-market monitoring.
• Develop and maintain product packaging specifications in line with regulatory and commercial needs.
• Conduct regulatory impact assessments for formulation or label changes.
• Monitor, interpret, and communicate changes to regulatory requirements (e.g., TGA guidelines, NICNAS, FSANZ, ACCC, and industry codes) to relevant internal stakeholders.
• Provide accurate and timely responses to regulatory queries from internal teams and customers.
• Assist with internal audits and regulatory inspections as required.

• Bachelor’s degree in Pharmaceutical Science, Regulatory Affairs, Health Science, or a related field.
• Minimum 2 years of experience in Regulatory Affairs within the Australian complementary or pharmaceutical industry.
• Demonstrated understanding of Australian regulatory requirements, especially TGA-listed medicines and TGO 92.
• Experience in preparing ARTG submissions and evidence documentation.
• Exceptional attention to detail, analytical, and critical thinking skills.
• Strong interpersonal and communication skills for cross-functional collaboration.
• Ability to work in a deadline-driven, fast-paced environment with shifting priorities.
• Proficiency in Microsoft Office Suite and familiarity with relevant regulatory submission systems.

• TGA regulations governing Listed Medicines, particularly requirements for inclusion on the ARTG.
• Therapeutic Goods Orders (TGO), especially TGO 92 relating to labelling and packaging.
• Complementary Medicines Guidelines, including evidence requirements and advertising standards.
• Australian Consumer Law, as it applies to health claims and product representation.
• Relevant standards under NICNAS, FSANZ, and GMP principles applicable to complementary medicines.

Benefits

As a Twoconnect employee, you get to enjoy the following:

• Work from Home
• Work-life balance
• Dayshift
• HMO benefits
• Government-mandated benefits
• Training and Development programmes
• Employee Engagement Events (company outings, fun activities, quarterly wellness and self-care sessions)
• Experience working with leading organisations
• Fun, supportive, and inclusive culture
• Dedicated Team Managers that look after your development