Regulatory Affairs Manager

About the company

Australian based pharmaceutical company with a global reach. This company has a portfolio of OTC, complementary medicines 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 providing regulatory guidance through all aspects of product lifecycle and new product development projects. This is a hands-on role in which you will oversee one regulatory affairs associate. You will report to The Head of Quality Assurance and Regulatory Affairs.

To be successful in securing this role, you will need experience with advertising approvals for consumer healthcare products. Around half of the role will involve managing advertising approvals and approvals for social media content.

Duties

• Liaising with regulatory bodies (e.g. TGA, NICNAS, AQIS)
• Maintaining and updating product approvals/registration
• Managing approvals for advertising and social media content in timely manner
• 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
• Act as a mentor and provide guidance to direct report for professional development

Skills and Experience

• Tertiary qualification in a relevant scientific discipline or equivalent
• Minimum 5 years' experience in regulatory affairs within consumer healthcare
• Experience mentoring team members and strong leadership qualities
• Must have current knowledge and experience with advertising approvals for consumer healthcare products
• Must have experience dealing directly with local Australian regulatory bodies - TGA, MedSafe, NICNAC etc

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.