Regulatory Affairs Associate
- Sydney, NSW
- Permanent
- Full-time
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference; the Regulatory Affairs Associate role is key to ensure continuity of supply via life cycle maintenance activities for our existing portfolio and to support the registration of new medicines in Australia. Compliance to local and global regulations is essential in the ever-changing regulatory environment.Key responsibilities for this role include:
- Deliver regulatory submissions within required timeframes;
- Ensure company databases and systems are accurate and current by drafting, updating, reviewing and verifying entries;
- Ensure our company’s change control system is accurate and current by creating, reviewing and/or completing change records as required;
- Maintain compliance with relevant regulations and codes and provide regulatory advice to company personnel as required;
- Maintain compliance and up-to-date training with internal Policies, Standard Operating Procedures, and Work Instructions, and adhere to company values and expectations;
- Complete allocated special projects;
- Collaborate cross-functionally to support submissions and projects where required;
- Support regulatory administrative activities as needed;
- Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives.
- Bachelor’s degree or equivalent in Pharmacy, Science or Chemistry.
- At least two years’ experience in regulatory affairs ideally with prescription medicines.
- Understanding of local and international regulatory guidelines.
- Capacity to investigate and evaluate a problem to develop effective solutions.
- Excellent communication skills (written and verbal).
- Ability to multitask and work to deadlines.
- Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframes.
- Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder).