Regulatory Affairs Manager

7 months ago

Sydney, Australia 4C Recruitment Full time

High growth and rapidly expanding Australian business
- Broad and varied role
- Flexible working conditions
- **Exciting opportunity for a Regulatory Affairs professional to join this leading ASX listed Medicinal Cannabis company.**:

- **Newly created role**:

- **Hybrid work on offer**

Reporting to the Head of Research and Development this broad regulatory role will see you involved in all aspects of this rapidly growing and expanding business as you take new products to market and develop and execute the regulatory strategy.

**Specifically your role will include the following**:

- Develop, execute and maintain regulatory processes and strategies for product submissions
- Contribute to product launch teams to ensure timely product introduction.
- Compile data and documentation to ensure compliant dossiers.
- Identify deficiencies in product dossiers and implement strategy.
- Maintain and enhance product dossiers
- Identify potential vendors and agencies ensuring compliance.
- Liaise with external agencies, suppliers or others to ensure timely, compliant submission dossiers
- Maintain adequate records and documentation of all regulatory matters
- Maintain appropriate regulatory licenses
- Participate in the GMP vendor qualification processes
- Maintain necessary systems and procedures
- Ensure compliance of promotional material, packaging and labelling legislations
- Coordinate and/or conduct audits of documentation or suppliers
- Support Quality Assurance as required

**To be successful in this role you will need the following skills and attributes**:

- Regulatory Affiars experience gained in Prescription or OTC environments
- Demonstrated experience working in a GMP manufacturing environment
- Experience with FDA submissions highly regarded
- Appropriate tertiary qualifications
- Well developed project management skills

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