Regulatory Affairs Specialist – Pharma & Supplements

Lipa Pharmaceuticals Limited; Sydney; On-site; AUD 80,000 - 110,000; Full time

Benefits offered by this job

Onsite car parking

Ongoing training and support

Rewards and Recognition Program

Job summary

Lipa Pharmaceuticals Limited is seeking an experienced Regulatory Affairs Associate to join our team on a fixed-term 12-month contract. The role supports regulatory compliance across the lifecycle of our pharmaceutical products in Australia, aligned with TGA requirements and international standards where relevant.

You will collaborate with QA, Manufacturing, R&D, and Commercial functions to prepare submissions, registrations, variations and regulatory documentation, maintain dossiers, and

Qualifications

• Tertiary qualification in Pharmacy, Science, Chemistry, Biotechnology, Life Sciences or related field.
• Experience in regulatory affairs, pharmaceutical manufacturing, QA or related regulated industry.
• Understanding of Australian regulatory requirements and the role of the TGA.
• Knowledge of GMP principles and pharmaceutical quality systems.
• Experience preparing and maintaining regulatory documentation.
• Strong attention to detail and ability to interpret technical information.
• Proficiency with Microsoft Office and document management systems.

Responsibilities

• Support preparation, compilation and submission of regulatory applications to the TGA and other authorities.
• Assist with product registrations, variations, renewals and ongoing regulatory maintenance activities.
• Ensure regulatory documentation is accurate, complete and compliant with applicable legislative and regulatory requirements.
• Prepare, review and maintain regulatory documentation, technical dossiers and supporting information.
• Assist in preparing responses to regulatory authority questions, requests for information and deficiencies.
• Maintain accurate regulatory records, submission trackers and approval documentation.
• Support the preparation and maintenance of product information, labelling and packaging documentation in accordance with regulatory requirements.
• Support ongoing regulatory compliance throughout the product lifecycle, from development and registration through to commercial supply and discontinuation.
• Assist in reviewing proposed changes to formulations, manufacturing processes, raw materials, specifications, packaging and labelling to identify regulatory implications.

Skills

Regulatory affairs

GMP knowledge

Documentation management

Attention to detail

Microsoft Office

Education

Tertiary qualification in Pharmacy, Science, Chemistry, Biotechnology, Life Sciences or related discipline

Tools

Microsoft Office

Job description

Lipa Pharmaceuticals Limited is seeking an experienced Regulatory Affairs Associate to join our team on a fixed-term 12-month contract. The role supports regulatory compliance across the lifecycle of our pharmaceutical products in Australia, aligned with TGA requirements and international standards where relevant.

You will collaborate with QA, Manufacturing, R&D, and Commercial functions to prepare submissions, registrations, variations and regulatory documentation, maintain dossiers, and