Regulatory Affairs Associate
- Smithfield, NSW
- $80,000-110,000 per year
- Permanent
- Full-time
The company is an Australian owned complementary medicine manufacturer, and they are looking for a QA and Reg Affairs Associate to join their team. The primary objective of this position is to ensure compliance with local regulatory requirements in Australia along with validation and technical documentation.Responsibilities include:
- Provide regulatory input into premarket, post market, and business activities respective to assigned portfolios.
- Review labelling, packaging, and promotional materials to ensure compliance with regulatory standards.
- Create templates for Quality and technical documentation.
- Manage change notifications, license renewals, and annual reports.
- Write and review SOPs, testing protocols, and ensure compliance with industry standards.
- Compile dossiers for the registration of new products.
- Establish and maintain raw material and finished product specifications.
- Manage the company's QMS.
- Coordinate product registration processes (research therapeutic functions of new products & prepare listing application.)
- Maintain existing licenses and acquire required licenses/certificates as needed.
- Maintain the company's Master Validation Plan (IQ/OQ/PQ, process validation and cleaning validations).
- Tertiary Qualifications in Chemistry or related field
- Extensive experience in Pharmaceutical QA and Validation
- Experience with internal and external audits
- Knowledge of Australian regulations and product registrations
- Previous experience in a complementary manufacturing facility will be beneficial
- Excellent verbal and written communication skills
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 Nikita on 02 8071 4290 or sydney@evolvescientific.com.au.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.