Manage new registration applications and approvals, no maintenance work.
Budget for Personal Development Training & ARCS Membership
Small local company that is part of a large global organisation - you get the best of both worlds!
About the company
A small, local pharmaceutical company that is part of a large, global organisation. Specialise in the distribution of pharmaceuticals and medical supplies to Australia, New Zealand and South Pacific region.
About the opportunity
The Senior Regulatory Affairs Associate will manage the end-to-end process for new product registration, variations, and approvals. You will then handover the product to the Life-Cycle team to manage the maintenance work. The portfolio includes a mix of Generic and Innovator Prescription products with some OTC and Listed products.
You will report to an experience Senior Regs Manager and be supported by two other experience regulatory affairs professionals.
Flexible working arrangement: Combination of WFH/Office post-covid
Prepare, review, and submit new registration applications to the TGA/Medsafe
Manage small number of variation applications
Prepare and submit associate GMP clearance applications
Provide guidance and support to the Business Development team on regulatory aspects of new projects
Develop regulatory strategies for new product to meet commercial objectives
Develop and maintain strong working relationships with regulatory authorities, business partners, and cross-functional departments
Maintain current knowledge of regulatory environment for prescription medicines
Mentor and train regulatory associate in team
Skills and Experience
5+ years of experience in Regulatory Affairs role within pharmaceutical industry
Working experience with TGA/Medsafe requirements for prescription medicines
Tertiary qualification in Scientific discipline (Pharmacy preferred)
Previous experience with clinical evaluation is ideal
Experience with Veeva or Trackwise would be ideal
Experience with electronic submissions
Excellent written and verbal communication and high attention to detail
Collaborative team player
Team & Culture
The team are very collaborative and supportive. They work independently on own portfolios and come together to problem solve and provide support with peer reviews.
How to Apply
Click apply or contact Joanna Murphy, Specialist Manager - Regulatory & Quality on +61 2 8877 8718 for a confidential discussion.