Regulatory Affairs Assocaite

    Location  - Melbourne - Melbourne
    Salary - $75000 - $90000 per annum + Super
    Job Type:Permanent
    Salary:$75000 - $90000 per annum + Super
    Location:Melbourne
    Reference:RE-12489771
    Contact Telephone:+61 2 82 51 1100

My client, a multinational pharmaceutical company that produce generic medicines, is looking for a Regulatory Affairs Associate to join their team in Melbourne. Due to growth of the business they are looking for someone to deal with all of their regulatory affairs activities.

This expanding company offers an excellent working environment and a very competitive salary. The successful candidate will have 3-4 years experience in regulatory affairs and a good understanding of both the regulations and submissions process for prescription and OTC medicines in Australia.

Key Responsibilities:

* Prepare and ensure cost-effective and timely registrations for product registrations and variations globally
* Liaise with internal departments locally and internationally
* Liaise with external regulatory authorities, manufacturers, distributors and licensors
* Negotiate with, influence and maintain effective relationships with key stakeholders
* Keep up to date with regulatory changes and competitor activities
* Provide regulatory advice to other departments and assist in strategy planning
* Contribute to the development of policies, systems and procedures
* Participate in the training and development activities

Skills and Experience Required:

* Tertiary qualifications in a medical, science or related field
* Established knowledge of regulatory affairs including an understanding of legislation, local and international guidelines and process.
* Proven experience in a Regulatory Affairs position
* Understanding of scientific principles relevant to the development of pharmaceutical products
* Understanding of the principles of GMP, GCP and GLP
* Strong skills in time management, problem solving and communication
* Able to work to and deliver on deadlines

If you are interested in this role the please apply online and contact Tommy White on 0282511100 for further information.

To find out more about Real please visit www.realstaffing.com