Senior Regulatory Affairs Associate (BBBH33488) Macquarie Park, Sydney, Australia

Benefits

 

The role offer exposure to working on all types of submission work, but especially exciting work in Oncology space.

Global organisation with strong pipeline

Support of a large regulatory team with long standing management

 

 

About the company

 

Our client is a large global pharmaceutical company based in Macquarie Park. The company are passionate about team and culture fit. They have a strong pipeline and hundreds of products across varying therapeutic areas including oncology, neurology and vaccines. With a large regulatory team there is strong support and the opportunity to excel in your career through broadening your knowledge

 

 

About the opportunity

 

Working within the Oncology team and reporting to the Regulatory Manager your main responsibility will be to ensure regulatory compliance of the prescription product portfolios. You will work closely with the quality and marketing teams to provide technical guidance and support.

 

 

Duties

  • Dossier preparation and submissions – Cat 1 and Cat 3 applications
  • Maintenance of product registrations
  • Artwork approvals, product information updates
  • Liaise with TGA and internal colleagues
  • Provide technical support to quality and marketing teams

 

 

Skills and Experience

  • Minimum 4 years regulatory affairs experience in pharmaceutical industry
  • Knowledge of Australian regulatory requirements and guidelines
  • Tertiary qualification desirable in Pharmacy, Pharmacology or equivalent
  • Strong relationship with the TGA and or Medsafe
  • Ability to work cross functionally
  • Excellent team player, proactive and competent
  • Effective verbal and written communication

 

 

Culture

 

Strong work ethic, determined, dedicated, and driven to achieve targets. Transparent and honest working together to meet common goals. Cross functional environment, working collaboratively across the business

 

 

How to Apply

 

Click apply or contact Davina Ocansey, Sourcing Consultant on +61 2 8877 8712 for a confidential discussion.

;