Senior Regulatory Affairs Associate- 30 Hours per week
An opportunity has arisen for a self-motivated, enthusiastic professional to join our team as a Senior Regulatory Affairs Associate.
Summary about this job
Other
Company: IDT Australia Limited
Location: Melbourne
Work type: Part Time
Salary: n\a
Phone: +61-7-7372-8989
Fax: +61-2-1548-3958
E-mail: n\a
Site: n\a
Detail information about job Senior Regulatory Affairs Associate- 30 Hours per week. Terms and conditions vacancy
- Pharmaceutical Industry
- Eastern Suburbs
An opportunity has arisen for a self-motivated, enthusiastic professional to join our team as a Senior Regulatory Affairs Associate.
The successful candidate will be responsible for:
- Maintenance of existing Drug Master Files and Drug Product licences; review and preparation of new Drug Master Files for both internal and external use
- Document preparation, review, sign-off and submission, including internal and external quality documents, Annual Reports
- Provision of Regulatory advice to internal and external customers and liaison with Regulatory agencies
- Preparation and presentation of Regulatory strategies
- Creation and maintenance of Regulatory Systems
- Preparing CMC and labelling supplements/variations to TGA and FDA
Required Skills and Experience:
- Bachelor of Science or equivalent
- Minimum five years Regulatory Affairs experience in the pharmaceutical industry
- Experience with TGA and FDA
- Tech Transfer experience highly desirable
- High level technical writing skills
- An understanding of the principles of cGMP, GCP and GLP
- Strong organisational skills and attention to detail
- Excellent verbal communication skills
- High level analytical and problem solving skills
- An ability to function independently and as part of a team.
About us
Founded in 1975, IDT Australia is an award-winning, publicly-listed Australian pharmaceutical manufacturing company, based in Boronia Victoria. Partnering with pharmaceutical leaders IDT specialises in the development and the commercial manufacture of high potency active pharmaceutical ingredients (API) and finished drug products for national and international distribution. IDT's culture is built on the success of its people. At IDT we value accountability, leadership, curiosity, quality, innovation and driving results.