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Job details

Location
Sydney
Salary
Competitive compensation and benefits package
Job Type
Full Time
Ref
BH-40619
Contact
Erin Cox
Posted
8 months ago

Job details

Location
Sydney
Salary
Competitive compensation and benefits package
Job Type
Full Time
Ref
BH-40619
Contact
Erin Cox
Posted
8 months ago
Benefits
  • Competitive compensation and benefits package
  • Opportunity to work from home part of the week
  • Access to ongoing professional development and growth opportunities
 
About the Company
 
Join a leading global healthcare company dedicated to enhancing the well-being of people in Australia and New Zealand through the development and marketing of a diverse portfolio.
 
About the Opportunity
 
As a Senior Regulatory Affairs Associate, you will play a pivotal role leading the regulatory strategy and execution for the consumer health portfolio. You will provide strategic regulatory direction to the ANZ Leadership Team, ensuring the appropriate regulatory approvals and product marketing authorizations are obtained. This is a unique opportunity to shape the local regulatory environment and have a significant impact on the product portfolio's success. Flexibility to work from home and in the office.
 
Duties
  • Provide strategic regulatory direction to the ANZ Leadership Team
  • Lead and manage the entire regulatory operations to obtain timely approvals
  • Define regulatory priorities and guide the Global RA team
  • Ensure compliance with existing product licenses and regulatory requirements
  • Review and approve promotional and non-promotional materials
  • Maintain regulatory files and databases, including GMP records
  • Develop and implement regulatory SOPs and processes
  • Keep abreast of relevant regulatory and industry activities
  • Liaise with external stakeholders and support audits and post-market activities
  • Foster cross-functional working relationships and represent the company in relevant committees
 
Skills and Experience
  • Bachelor's Degree in Life Sciences
  • Experience working in regulatory affairs, ideally in Consumer Health
  • Experience in leading end-to-end new product registrations
  • Strong knowledge of regulatory aspects in Australia and New Zealand
 
Culture
 
Our client appreciates the unique contributions of every team member, and their workplace fosters professionalism, cooperation, and a welcoming atmosphere, providing an ideal setting for personal and professional growth.
 
How to Apply
 
Click apply or contact Gemma Staddon on 02 8877 8776 or Erin Cox on 02 8877 8734  for a confidential discussion.

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