Regulatory Affairs Associate

About company/role:

• Major pharmaceutical company
• Based in Melbourne CBD
• 12 month casual contract
• Monday-Friday, full time hours
• Hybrid position (3 days onsite, 2 days from home)
• Regulatory affairs for APAC region

Duties, but not limited to:

• Contribute to the compilation of high quality documentation for submissions in the region.
• Lead the preparation and contribute to briefing packages for HA meetings associated with established products.
• Responsible for regulatory submissions such as new license applications, renewal applications, change applications, PSUR applications and other documentations required.
• Submit relevant regulatory documentation in a timely manner.
• Responsible for the overall coordination and dispatch/submission of responses to HA questions.
• Support GRL/assigned product representative or other GRAST members for strategic planning and preparation of responses to complex scientific questions requiring product expertise.
• File CAT1 and CAT3 applications independently as per TGA requirements

Skills/experience:

• Tertiary education in Biology, Medical Science, Pharmacy, Drug Regulatory Affairs or similar. Preferably a post-graduate qualification.
• Must have proven regulatory experience in a similar position within the pharmaceutical industry
• Knowledge of regulatory affairs in Australia and New Zealand
• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product
• Understanding of GMP, GCP and GLP principles
• Strategic and tactical thinking ability, hands-on operational approach and business planning orientated
• Excellent written and verbal communication skills, displays leadership qualities
• Ability to work in a fast-paced environment with changing priorities

Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).  
Or, if you have any questions, please contact Linda on 03 9040 1630.

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, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 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.