- Full-time permanent position home-based in Sydney, Melbourne or Brisbane.
- Hands-on regulatory role across human medicines.
- Client-facing position with strong project delivery focus.
Our client, a global regulatory and scientific consulting organisation, is seeking a Senior Regulatory Affairs Associate to join their pharma regulatory team. This is an excellent opportunity for an experienced regulatory professional to take ownership of regulatory projects, work closely with clients, and contribute to high-quality regulatory outcomes across prescription medicines and biological products.
You will play a key role in executing regulatory activities, driving regulatory strategy, and ensuring successful delivery of client projects within a collaborative consulting environment.
Your Key Responsibilities:
- Develop and maintain strong client relationships.
- Participate in regulatory processes to gain and maintain marketing authorisations, including applications, renewals, and variations.
- Prepare, review, and compile regulatory documentation for human and veterinary medicinal products.
- Act as a key liaison between clients and Health Authorities, including support for scientific advice procedures.
- Plan and execute client projects in line with KPIs, coordinating internal teams and external partners.
- Provide regulatory strategy guidance to colleagues and clients.
- Maintain regulatory intelligence and actively share knowledge across the team.
- Present seminars and lectures to colleagues, clients, and professional audiences.
- Contribute to internal process optimisation and quality systems.
- Support commercial, marketing, and business development activities, including proposal input.
- Provide on-site regulatory support to clients as required.
- University degree in Life Sciences.
- Proven experience in Regulatory Affairs within prescription medicines/biological products.
- Strong knowledge of marketing authorisations, variations, and lifecycle management.
- Experience preparing and reviewing regulatory submissions and technical documentation.
- Ability to manage multiple projects and prioritise competing tasks.
- Strong analytical and problem-solving capability with a pragmatic approach.
- Excellent written and verbal communication skills with confident presentation style.
- Experience in a consulting or CRO environment will be highly regarded.
