Excellent mentors as you will learn from experienced regulatory affairs professionals
Gain exposure to all regulatory affairs activities for a range therapy areas.
Develop your PV skills while supporting in this area too
Innovator pharmaceutical company with a respected brand in the market
Flexible hybrid working arrangement.
Positive and friendly team and company-wide culture
About the company A reputable and well-established, global pharmaceutical company. Broad range of products and a strong pipeline of innovative products.
About the opportunity This is a combined RA:PV role with a focus on RA (regulatory affairs). The ideal person for this role will have some exposure to both regulatory affairs and PV. You will provide operational support to the Regulatory Affairs team and the Pharmacovigilance team.
Support with the execution of the regulatory plan by procuring relevant documentation for submission of high-quality applications within the relevant time frames
Ensure product compliance with local regulatory requirements and quality systems
Ensure compliance of product information documents with regulations
Tracking regulatory procedures and archiving correspondence
Assist Pharmacovigilance (PV) team in reporting Adverse Events and submit safety reports to relevant bodies
Provide operational support with Regulatory Affairs and Pharmacovigilance processes
Skills and Experience
Degree qualified in relevant scientific discipline; pharmacy, pharmacology, chemistry are preferred
Must have 1-2 years’ experience in Regulatory Affairs role working with prescription medicines
Experience with PV activities would be ideal
Experience with local TGA or Medsafe regulatory bodies is preferred.
Must have clear and effective communication
Personable, team player with strong work ethic
How to Apply Click apply to submit a resume in the first instance. Following this, if you would like more information, please contact Joanna Murphy, Specialist Manager on +61 2 8877 8718 for a confidential discussion.
** Please note you must reside in Australia to be considered for this position and receive correspondence on your application **