Regulatory Affairs Associate

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 is Australia’s leading manufacturer of complementary medicines, specialising in vitamins, pharmaceuticals, and health food supplements. We have the capacity to produce a wide range of products including tablets, hard and soft capsules, liquids, powders, creams, gels, and probiotics.

We are proud to have been recognised by Complementary Medicines Australia as the ‘High-Quality Manufacturer of the Year’ on nine occasions for the exceptional products we create.

The Opportunity

We currently have an opportunity available for an experienced Regulatory Affairs Associate to join our dedicated team on a fixed term 12 month contract.

The Regulatory Affairs Associate is responsible for supporting the regulatory compliance of pharmaceutical products throughout their lifecycle, ensuring that products meet applicable Australian regulatory requirements and international standards where relevant.

The role supports the preparation, submission, maintenance and management of regulatory documentation, product registrations, variations and regulatory approvals in accordance with the requirements of the Therapeutic Goods Administration (TGA), Australian legislation and relevant regulatory guidelines.

Working collaboratively with Quality Assurance, Manufacturing, Research & Development, Technical Services and Commercial teams, the Regulatory Affairs Associate helps ensure that pharmaceutical products are developed, manufactured, labelled and supplied in accordance with approved regulatory requirements.

The role contributes to maintaining regulatory compliance, supporting business continuity and enabling the timely introduction and ongoing supply of safe, effective and quality pharmaceutical products.

What we offer

• Immediate start with onsite car parking
• Work with a results-driven and passionate team
• Ongoing training and support
• Guidance by a supportive management team with a clear vision
• Employee benefits, including a Rewards and Recognition Program

Responsibilities

• Support the preparation, compilation and submission of regulatory applications to the TGA and other relevant regulatory authorities.
• Assist with new product registrations, product 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.
• Tertiary qualification in Pharmacy, Science, Chemistry, Biotechnology, Life Sciences or a related scientific discipline.
• Previous experience in regulatory affairs, pharmaceutical manufacturing, quality assurance or a related regulated industry.
• Understanding of Australian pharmaceutical regulatory requirements and the role of the TGA.
• Working knowledge of GMP principles and pharmaceutical quality systems.
• Experience preparing, reviewing or maintaining technical and regulatory documentation.
• Strong attention to detail and ability to interpret technical information.
• Proficiency in Microsoft Office applications and document management systems.

Please Note:

Lipa Pharmaceuticals has a strong commitment to health and safety, with a pre-employment medical requiring successful completion, prior to an offer being made. We do not accept unsolicited applications from third parties. Applicants must be eligible to work in Australia. Additionally, as our facility is not accessible by public transport you will need your own transportation to get to work.

Lipa Pharmaceuticals is an Equal Employment Opportunity (EEO) employer. We are committed to providing a diverse and inclusive work environment for all employees and applicants, regardless of race, colour, nationality, gender, age, disability, religion, sexual orientation, gender identity, or any other characteristic protected by law. We encourage individuals from all backgrounds to apply