Senior Regulatory Affairs Associate
BH-233072
Posted: 26/05/2023
- Market competitive compensation package
- Australia New South Wales Sydney
- Permanent
-
Life Sciences
Senior Regulatory Affairs Associate
The role
We are looking for a highly motivated Senior Regulatory Affairs Associate to join the team at this dynamic, rapidly growing global biotechnology company with a focus on developing molecularly-targeted and immuno-oncology cancer therapeutics.
The successful candidate will be responsible for ensuring the regulatory compliance of therapeutic products in Australia and New Zealand, developing and executing regulatory strategic plans in conjunction with project teams, and supporting the clinical trial and marketing authorization activities across our portfolio. We require someone who is experienced in prescription medicine regulatory affairs and has excellent organizational and communication skills.
Responsibilities
If you are a highly motivated, collaborative, and passionate individual with a proven track record in regulatory affairs, we encourage you to apply.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
The role
We are looking for a highly motivated Senior Regulatory Affairs Associate to join the team at this dynamic, rapidly growing global biotechnology company with a focus on developing molecularly-targeted and immuno-oncology cancer therapeutics.
The successful candidate will be responsible for ensuring the regulatory compliance of therapeutic products in Australia and New Zealand, developing and executing regulatory strategic plans in conjunction with project teams, and supporting the clinical trial and marketing authorization activities across our portfolio. We require someone who is experienced in prescription medicine regulatory affairs and has excellent organizational and communication skills.
Responsibilities
- Ensure regulatory compliance of therapeutic products in Australia and New Zealand
- Develop and execute regulatory strategic plans in conjunction with project teams
- Provide expert regulatory input to strategic decision-making
- Prepare, submit, and support clinical trial applications and variations in Australia and New Zealand
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives
- Maintain current knowledge of relevant regulations, including proposed and final regulations
- Support activities such as audits, regulatory agency inspections, medicine shortages or product recalls
- A positive 'can do' attitude
- Life sciences degree
- Proven regulatory experience in prescription medicine regulatory affairs
- Experience of working on regulatory applications in Australia and New Zealand
- Experience of working on clinical trial applications for Australia and New Zealand is a plus
- Excellent organizational and communication skills
- Fluent in English (both in speaking and writing)
- Full working rights in Australia (Citizen or PR)
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- Full-time working from home (with an option to work from the Sydney office)
- In-house and external learning and development opportunities
- Fantastic benefits program
- Work with a dynamic team of collaborative, supportive, diverse and fun professionals
If you are a highly motivated, collaborative, and passionate individual with a proven track record in regulatory affairs, we encourage you to apply.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.