Regulatory Affairs Manager: Part-time/Full-time (BBBH34146) Macquarie Park, Sydney, Australia

Salary: + Super + Bonus

About the company

 

Australian based pharmaceutical company with a global reach in consumer . This company has a portfolio of OTC, complementary and medical device products, including many household brand names. This is a stable role with a company that has a strong product pipeline.

 

 

 

 

About the opportunity

 

The Regulatory Affairs Manager will be responsible for managing all regulatory activities and providing regulatory guidance through all aspects of new product development projects. This position will have one direct report, and will report to The Head of Quality Assurance and Regulatory Affairs.

 

We are open to applicantions from candidates who are looking for a full-time 5-days per week role, and also applications for part-time 2-3 days per week. The part-time role will work alongside the current RA Manager to cover the full week.

 

 

 

 

Duties

  

  • Liaising with regulatory bodies (e.g. TGA, NICNAS, AQIS)
  • Maintaining and updating product approvals/registration
  • Evaluating potential new products to determine regulatory requirements
  • Obtaining appropriate product approvals in line with new product development plans
  • Provide guidance to cross functional team on advertising and promotional material
  • Creating and reviewing technical files for products to ensure compliance to regulations
  • Communicate with overseas suppliers to ensure GMP approvals are maintained
  • Supervise and manage the activities of personnel that report to position
  • Act as a mentor and provide guidance to direct report(s) for professional development

 

 

 

 

Skills and Experience

 

  • Tertiary qualification in a relevant scientific discipline or equivalent
  • A minimum 7 years’ experience within the OTC pharmaceutical industry
  • Must have hands-on experience in regulatory affairs working with consumer healthcare products and advertising guidelines
  • Previous managerial experience within Regulatory Affairs would be ideal.

 

 

 

 

 

Culture

 

Small to medium sized, family-owned business. Face-paced, supportive and collaborative team environment. 

 

 

 

 

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

 

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