Regulatory Affairs Associate

2 weeks ago

Alexandria, Australia Pharmacare Group Full time

**Introduction**:
BioMedica Nutraceuticals is a fast growing Australian company focused towards the manufacture of high quality natural medicines. Founded by Naturopaths, BioMedica has created a product range and support structure to exclusively serve the needs of the professional holistic practitioner.

**Description**:
About the Role

As part of Regulatory Affairs team, this role is primarily responsible for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Australia.

This includes preparing, submitting and tracking regulatory submissions, and maintaining compliance for product portfolios in a solutions-oriented manner in line with business strategies and priorities.

**Some key areas of responsibility**:
New product and ingredient research for use, compliance, suitability and availability
Assisting external NPD consultant

Regulatory (TGA) compliance

Adjustment of ARTG claims when appropriate
Responding to TGA reviews and audits
Create and check labels for compliance
Manage stability program

General administration

ARTG competitor updates
Maintain Procedures/operating manual
Maintain project management software (ASANA)
Maintain internal product databases (eg “free from” list)
Assist with manufacturing quotes
Manage manufacturing queries

**Skills and Experiences**:
About you
- Computer literate (Outlook, Excel, Word, Power-point)
- Strong written and verbal English communication skills
- Knowledge of TGA and regulatory requirements
- Strong attention to detail
- Exceptional organisational skills
- Ability to work to tight deadlines
- Pro-active attitude
- Ability to work with all external consultants and manufacturers

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