Regulatory Affairs Specialist

As a leading manufacturer of nutritional supplements and other health-building products, we are dedicated to enhancing the wellbeing of our customers - through research, development and delivery of effective nutritional products. It is our mission to contribute to the lives of our customers, employees, suppliers and the communities we serve, in a cooperative and sustainable manner.

Are you an expert in regulatory affairs for complementary medicines? Want to learn how your skills can help improve people's health while respecting the resources of our planet? If so, we have an exciting opportunity for you to join us as a Regulatory Affairs Specialist In this role you will be liaising with regulatory bodies to obtain licensing for our products. If this kind of work gets you excited, we would love to hear from you.

Monday to Friday 9:00 am - 5:00 pm (Flexible Hours; Hybrid Model)

**About the role**:

- Ensure that all products are developed and advertised in accordance with regulatory requirements
- Provide technical expertise in the development, formulation and evidence assembly of new and existing products, and analysis of product information for compliance to local regulations
- Formulate and develop new products, in accordance with TGA/FSANZ/applicable Asian markets and Factors Group standard operating procedure (SOP) requirements
- Project manage all regulatory projects by liaising with the NPD, Quality and Regulatory departments to ensure that projects are executed against strategy
- Ensure that all product listings and product labels are kept current with regards to the product formulations, specifications, and supplier information
- Monitor government and other regulatory bodies and keep up-to-date on regulatory requirements and issues
- Identify and deliver recommendations on new product and range opportunities based on emerging trends, creative ingredient use, evidence, ingredients, market and competitor movements
- Involvement in key quality and regulatory aspects of bringing new products to market
- Responsible for assessing the regulatory impact on any change control
- Provide appropriate technical support to other departments as needed
- Conduct post-launch audits, monitoring, analytics and reporting to ensure continuous process improvement. Raise areas of risk for business evaluation. Respond to regulator complaints, post-market surveillance and queries as required
- Provide regular reports on Regulatory Affairs activity
- Review and approve assigned promotional and education content for compliance to local regulations
- Initiate competitor and/or industry complaints as required
- Project manage, develop, and oversee product registration/dossier collation in Australia and designated oversees countries, contributing to key strategic projects
- Provide technical expertise in the assessment and assembly of relevant source documentation into registration files for successful regulatory submission and approval into international markets
- Drive regulatory expertise in generating systems, procedures and process improvement enabling efficiency
- Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMP)
- Strictly adhere to and observe all safety policies as outlined in the company policies and training sessions
- Other duties as assigned

**Skills and experience**:

- Completion of a Bachelor’s degree in a science discipline
- Minimum 2 years’ experience in Regulatory Affairs (either in pharmaceutical, nutraceutical or complementary medicine manufacturing)
- Capable of dealing with government and other regulatory bodies (TGA/FSANZ/ARTG)
- Thorough knowledge of therapeutic goods formulation, manufacturing, and quality processes
- Strong knowledge of QA and relevant regulatory requirements
- Strong proficiency with MS Office (Word, Excel, PowerPoint, Outlook, and SharePoint)

**Benefits and perks**:

- We believe our people are one of our greatest assets and we strive to provide our employees with a challenging and rewarding work environment
- You will be joining a globally recognised company with big expansion plans for Australia
- We are a dynamic company with room to grow and develop
- We offer a very competitive salary
- We also offer staff discounts on all our products

All Internal applicants will be given priority for consideration for the first five business days that this position is posted. After that five days, Internal applicants will be considered along with all other applicants; however, are guaranteed at minimum a call from the Talent Acquisition team.

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