Experience

Bio Concepts

• Australia
• Wellness and Fitness Services
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Jan 2020 - Present

  - Preparation of evidence packages: Perform literature reviews of relevant and credible resources and compile in Bio Concepts evidence package format to substantiate therapeutic claims. - Preparation and review of product specifications: Review product specifications for regulatory compliance and provide required amendments to external contract manufacturers as appropriate. - Preparation and review of product labels: Review product labels for regulatory compliance and provide required amendments to external label suppliers as appropriate. - Preparation of TGA regulatory submissions: Prepare and submit product related regulatory submissions to assist with the maintenance of regulatory compliance. - Compilation of regulatory dossiers for International markets: Review regulatory requirements of selected international markets and compile requested information for dossier submission. - Review of marketing material for regulatory compliance: Review marketing material against the Therapeutic Goods Advertising Code and provide recommendations to assist with the maintenance of regulatory compliance. - Assisting with the implementation of therapeutic goods reforms: Assist with the implementation of Therapeutic reforms as appropriate, such as the implementation of the Therapeutic Goods Permissible Indications and the implementation of Therapeutic Goods Order (TGO) No.92 – Standards for labels of non-prescription medicines. - Education and Training: Perform research on specific topics to provide suitable information for evidence package compilation, practitioner education and new product development. Create, edit and present Product and Category education / training sessions for both internal and external stakeholders.



Metagenics ANZ

• Australia
• Wellness and Fitness Services
• 100 - 200 Employee

• Claim review officer & Regulatory Affair team

  • Jan 2019 - Jan 2020

  • Conduct accurate and timely regulatory assessment of current Claim Substantiations against the TGA Levels of Evidence Guidelines and update where necessary • Submit an updated Claims Substantiation document to the Regulatory Affairs specialists for final approval; containing the Permitted Indications and supporting evidence • Review labels and/or advertising materials for compliance to the relevant regulations and Metagenics (Aust) specifications and Marketing authorizations • Prepare Medicine Listing applications for later submission by Regulatory Affairs • Submit draft EBS Applications • Accurately review and produce documentation to meet all applicable Regulatory Authorities/Agencies requirements • Scientific research and systematic literature reviews of evidence to support complementary medicines • Non-repetitive issues found in the Claim Substantiation documents • Ensure the best Indication is chosen to represent Marketing claim



North Buderim Pharmacy

• Pharmacy Technician

  • Feb 2017 - Dec 2018

  • Provided S2/S3 differential diagnosis, counselling and product selection. • Gain invaluable knowledge and expertise through voluntary weer, contributing to the excellence service delivery. • Demonstrated dispensing experience using Aquarius dispensing software. • Performed store management activities, ensuring that all of the stock are arranged well to ensure proper tracking. • Carried out Webster packing. • Provided S2/S3 differential diagnosis, counselling and product selection. • Gain invaluable knowledge and expertise through voluntary weer, contributing to the excellence service delivery. • Demonstrated dispensing experience using Aquarius dispensing software. • Performed store management activities, ensuring that all of the stock are arranged well to ensure proper tracking. • Carried out Webster packing.



Liptis Nutrition

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Medical Sales Representative

  • Oct 2014 - Aug 2016

  • Maintained and ensured the position of strategic brands in the market. • Raised the engagement with the Medical Society; monitored sales and stocks in order to maintain business security. • Sponsor, run and attend scientific meeting based on the insights and needs of the consumer base. • Maintained and ensured the position of strategic brands in the market. • Raised the engagement with the Medical Society; monitored sales and stocks in order to maintain business security. • Sponsor, run and attend scientific meeting based on the insights and needs of the consumer base.



Dablan Pharmacy

• Pharmacist in charge

  • Jun 2006 - Dec 2013

  • Execute day-to-day management of store, dispensary and team operations. • Provided professional patient counselling and rendered complete patient care solutions. • Perform accurate and efficient dispensing of prescriptions using different software. • Supervised Intern, Student Pharmacists and dispensary Assistants. • Carried out dispensary inventory management and order processing. • Liaise with insurance companies, with tasks such as submitting insurance claims, ensuring payments and solve claims disputes. • Performing several administrative tasks such as payroll, stock control, and medication purchase requests. • Supported and grew new business strategies to develop clinical practice, procedures and protocols.



Pharmaceutical Labs

• Quality control Pharmacist & Regulatory affair related matters responses

  • May 2010 - Aug 2013

  • Follow with all ministry of health related matters and responses • Scientific research & Systematic review of evidence to support the listed medications • Maintain the microbiological, non-viable and chemical monitoring of the compounding centre • supervises experiments and tests compounds • Operating analytical instruments • keeps a record of laboratory records • Preparing samples and specimens. • Recording and interpreting the results for presenting them to the management. • Using computers for complex mathematical calculations and preparation of graphs.