Alex Gooding
Back to Team
Alex Gooding
Senior Recruitment Consultant - Life Sciences
Jobs by Alex Gooding.
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.
Senior Quality Assurance Associate
- Sydney
- Competitive Salary Package
Benefits Opportunity to progress into a management role. Work across a variety of OTC products. Collaborative and supportive team culture. Team lunches. About the company An established multinational company specialising in generic medicines across multiple therapeutic areas. With over 20 years of experience, the company is known for its dynamic work environment and vibrant culture. This role offers hands-on experience with a variety of products and includes a career development plan leading toward a management position, creating an ever-evolving and rewarding workplace. About the opportunity This Senior Quality Associate role offers a chance to shape the company's expanding quality systems and manage a diverse portfolio in OTC medicine. The role includes overseeing and developing the QMS, conducting audits (including international travel), and improving processes to ensure compliance. Within 12 - 18 months, you'll have the opportunity to move into a managerial position with oversight responsibilities for a growing team. Duties Manage and improve current QMS, including change controls and document updates. Conduct internal and external audits, including international trips. Oversee GMP clearance documentation and processes. Collaborate with teams to develop SOPs and streamline roles. Lead quality assurance projects and monitor compliance. Prepare detailed reports and handle product complaints. Drive continuous improvement initiatives. Skills and Experience Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or related field. 3-5 years of experience in quality assurance, particularly with OTC and prescription medicines. Experience with QMS management or setup. Confident in managing regulatory interactions with the TGA. Strong communication and problem-solving skills. Managing GMP documentation and processes. 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.
COMBINED EXPERIENCE
At HPG, we pride ourselves on bringing together a diverse group of professionals with extensive backgrounds in the healthcare recruitment industry. Our combined years of experience and specialised knowledge ensure that we deliver unparalleled service to our clients and candidates. By working collaboratively, we harness our collective expertise to meet and exceed your goals and expectations, providing tailored solutions and exceptional support every step of the way. Discover how our unified team effort drives success in every project we undertake.
Jo Turner
Divisional Manager - Business Support, Operations and Life Sciences
Erin Cox
Recruitment Consultant - Life Sciences
Glenn Carter
Founder & Managing Director
Gemma Staddon
Divisional Manager - Life Sciences
Davina Ocansey-Gibson
Senior Recruitment Consultant - Life Sciences