Senior Regulatory Affairs Associate

Benefits

• 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

Duties

• 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.