Regulatory Affairs

Regulatory Affairs Associate

• Sydney
• Competitive Salary Package

Benefits Opportunity to build Cat-1 to Cat-3 prescription portfolio. Career development opportunities. Annual awards ceremony with rewards for outstanding contributions. Vibrant and collaborative working environment.   About the company An established multinational Australian company specialising in hard-to-register generics across a variety of therapeutic areas, including dermatology, oncology, and cardiology. With over 20 years of experience, they operate across multiple markets, including Australia, New Zealand, India, the UK, and more. The company fosters a collaborative and supportive environment where employees are encouraged to take on diverse and challenging projects.   About the opportunity This Regulatory Affairs Associate role will support the team by managing regulatory submissions across their Cat-1 to Cat-3 prescription products. You will play a key role in preparing regulatory documentation, liaising with the TGA and local teams to ensure timely, high-quality submissions. The role offers a mix of challenges across various therapeutic areas, and provides career growth opportunities into senior positions within the business.   Duties Perform gap analysis on regulatory dossiers and resolve deficiencies before submission. Prepare and submit regulatory registration applications for prescription products in Australia and New Zealand. Prepare Module 1 elements such as product info, labels, and risk management plans. Submit variation applications (SAR, SRR, Category 3) as required. Collaborate with overseas affiliates on regulatory applications. Review artwork and labelling for compliance. Manage GMP clearance submissions. Maintain regulatory SOPs and ensure compliance with industry standards. Participate in regulatory project meetings and provide advice to business teams.   Skills and Experience Degree in a scientific or pharmaceutical field. 2–4 years of experience in prescription regulatory affairs, high-level OTC experience will be considered. Experience with Category 1 submissions to the TGA will be beneficial. Strong communication and organizational skills. Ability to manage time and responsibilities independently.   Culture The company fosters a collaborative and supportive culture with a focus on teamwork, continuous learning, and collaboration. Employees value the variety of projects and the rewarding nature of their work, including early finishes and celebrations for team milestones.   How to Apply Click apply or contact Alex Gooding, Senior Recruitment Consultant on 02 8877 8775 for a confidential discussion.   About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care.   Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific. Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs. Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse. Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.