Preparation, compilation and submission of Marketing Application and variations for new or life cycle products or other documentation
Prepare applications such as export listings, GMP licence/certificates, Certified Products Details.
Help prepare the regulatory component of the life cycle documents.
Prepare dossier preparation check/tracking lists and if necessary, requests missing documents from the operational departments including monitoring of deadlines.
Help review guidelines and coordinating/preparing comments.
Work with the product managers/specialists in preparing documentation, QC checks and submission of regulatory applications or responses.
Data entry and maintenance in/of regulatory systems and to provide outputs for e.g. audit requests.
Work with relevant product managers/scientists to prepare standard operating procedures/work instructions or check/tracking lists.
Work with the team leads or delegate to monitor the metrics/statistics, reports etc. for presentation purposes.
Working with managers/team leads to monitoring and training requirements.
About you –
1-year tertiary science or proven regulatory experience
Function-related training in Regulatory Affairs
Flexibility to work in a global regulatory cross-cultural work environment.
Team player with a demonstrated ability to develop constructive and effective relationships.
Awareness of regulatory affairs and initiate or execute improvement initiatives
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 Priyanka or Cathy 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.
Submission Form
Submit your message along with your CV attached, and one of our specialists will be in touch.