Regulatory Affairs Associate

Benefits

• 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.
 
 
 
Duties

• 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
• License maintenance activities; label changes, CMC changes, license renewals
• 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 **