SENIOR REGULATORY AFFAIRS SPECIALIST at Abbott
Macquarie Park, New South Wales, Australia -
Full Time


Start Date

Immediate

Expiry Date

02 Nov, 25

Salary

0.0

Posted On

03 Aug, 25

Experience

7 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Responsibilities
  • Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.
  • Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.
  • Provide assessment on product and manufacturing changes in relation to regulatory actions.
  • Review and approving promotional material for compliance with relevant regulations and codes.
  • Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders
  • Provide training and guidance on Regulatory topics to stakeholders where applicable.
  • Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.
  • You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.
Loading...