Opportunity and Company:
Ideally based in the Sydney Office , we are looking for a Regulatory Affairs Associate / Senior Regulatory Affairs Associate reporting into the Regulatory Affairs and Quality Manger to join a growing team in a global pharma. This role is ideal for somebody with 1-2 years’ experience in pharmaceuticals that is looking for the perfect opportunity to learn and grow in a role. The role offers an excellent salary and bonus scheme.
The company boasts an excellent portfolio of products and is one of the major global players in the Pharmaceutical industry
- Providing the regulatory compliance of all products, as well as undertaking research and evidence reviews to support claims and indications and the drafting of product listings and registrations.
- To act as the main liaison between the Sales and marketing departments as well as providing the regulatory advice to the NPD teams and contributing to the process, vetting new products ingredients and reviews.
- Ensure product development and formulation compliance with relevant regulations including product and label accuracy.
- Liaise with manufacturers and the QA Manager on regulatory matters and assist with product related complaints. .
- Review drafts of product listings / registration; domestic and international markets
- Assist in the development, implementation and maintenance of regulatory procedures, SOPs, and data management to ensure due diligence and sponsor obligations are maintained in the domestic market and provide Regulatory recommendations to the business.
- A degree level qualification in a relevant science related field (Health, Medical, Life Sciences, Pharmacy)
- 1 -2 years of experience working in a Regulatory Affairs role in Australia is desirable, however could consider somebody less or more experienced depending on the candidates individual experience.
- An understanding of Regulatory requirements in non-therapeutic and therapeutic products
- Experience in Pharmaceuticals or Devices is highly regarded for this role but not essential.
- Experience Implementing Regulatory Compliance both domestically and international highly regarded.
- Excellent communication skills both Written and Verbal.
- Must have full working rights in Australia
How to apply:
For more information on this role, please apply now, or email me for more information on dean.coleman @ nesgt.com or alternatively please feel free to give me a call for a confidential discussion on 02 9696 8016