Regulatory Affairs Officer
2 weeks ago
An Australian pharmaceutical company is looking for a full time Regulatory Affairs Officer to join our regulatory team and manage the end-to-end process for product registration, variations and approvals in Australia and globally. The portfolio consists of veterinary and human medicinal products.
**Responsibilities include but not limited to**:
- Maintain an in depth knowledge of global regulatory requirements and updates
- Preparation, submission, and finalisation of regulatory submissions, and marketing authorisation variations in Australia, Europe, Asia, Middle East and South America.
- Liaise with regulators, distributors and end users as required
- Providing regulatory support to company personnel
- Maintaining the Pharmacovigilance System, assisting with investigations and collecting/monitoring of information
- Assist with customer complaints and product enquiries.
**Skills and experience**
- Experience in Regulatory Affairs and/or Quality experience within pharmaceutical industry required
- Working experience with TGA, European and APVMA legislation for prescription medicines
- Tertiary qualification in Scientific discipline (Pharmacy or equivalent)
- Strong communication skills (verbal/written/presentation/relationship building) and the ability to work collaboratively with different stakeholders and regulators
- Experience and/or knowledge with sterile product manufacturing processes and testing would be advantageous
Pay: $85,000.00 - $90,000.00 per year
Schedule:
- 8 hour shift
**Education**:
- Bachelor Degree (preferred)
**Experience**:
- regulatory affairs: 2 years (preferred)
Work Authorisation:
- Australia (required)
Work Location: In person
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