Regulatory Affairs Associate
- North Sydney
- Salary:AU$100000 - AU$110000 per annum + Super + Bonus
Job details
- Location
- North Sydney
- Salary
- AU$100000 - AU$110000 per annum + Super + Bonus
- Job Type
- Contract
- Ref
- 37534
- Contact
- Poornima Jayakumar
- Contact email
- Email Poornima
- Contact phone
- +61 2 8877 8702
- Posted
- 3 days ago
Job details
- Location
- North Sydney
- Salary
- AU$100000 - AU$110000 per annum + Super + Bonus
- Job Type
- Contract
- Ref
- 37534
- Contact
- Poornima Jayakumar
- Contact email
- Email Poornima
- Contact phone
- +61 2 8877 8702
- Posted
- 3 days ago
Benefits
- Opportunity to work on exciting pipeline products including an NCE application
- Global healthcare company
- Broad product range - prescription, OTC, listed medicines
- Competitive salary
- Excellent opportunity for growth and professional development
- Flexible working
About the company
A global specialist pharmaceutical company that has been bringing transformative healthcare products to patients for over a century. Boutique organisation committed to helping people to live better and healthier lives.
About the opportunity
A great opportunity to join this highly successful global pharmaceutical team and work on a diverse range of products. The portfolio of products includes Rx, OTC, and listed products. You will be reporting to the Regulatory Affairs Manager ANZ.
The ideal candidate will have a willingness to learn and the flexibility and adaptability to work across the full product range.
**Exciting opportunity to support with upcoming NCE application**
Duties
- Maintain regulatory compliance of products and ensure regulatory records are always up to date
- Responsible for variation applications for the range of products
- Support the RA Manager with new applications including one upcoming NCE
- Liaise with key stakeholders and provide support and guidance on regulatory requirements
- Review and evaluate proposed product labelling and manufacturing changes for regulatory filing solutions
- Involved in supporting maintenance of quality records and liaising with global team
Skills and Experience
- Tertiary qualification in relevant scientific discipline
- Minimum of 3 years of Australian regulatory experience in the pharmaceutical industry
- Substantial knowledge of TGA and Medsafe requirements for therapeutic goods
- Experience with compilation, submission and maintenance of regulatory files is an advantage
- Excellent communication and presentation skills
- Willingness to learn
- Ability to work autonomously and collaboratively across sectors
Culture
Very positive and close-knit environment, where flexibility and teamwork are at the heart of what they do.
How to Apply
Click apply or contact Joanna Murphy, Specialist Manager on +61 2 8877 8718 for a confidential discussion.
Similar jobs
2 months ago
Regulatory Affairs
Senior Regulatory Affairs Associate
- North Shore, New South Wales
- Attractive salary package
BenefitsManage new registration applications and approvals, no maintenance work.Budget for Personal Development Training & ARCS MembershipSmall local company that is part of a large global organisation - you get the best of both worlds! About the company A small, local pharmaceutical ...
4 days ago
Regulatory Affairs
Regulatory Affairs Associate - Post M...
- North Shore
- Negotiable
BenefitsWork for the global leaders in medical technologyAttractive/Competitive salaryGreat opportunity for professional developmentExcellent employee engagementFlexible workingAdditional benefits, rewards and recognitionAbout the companyThe company offers a diverse array of innovat...