Regulatory Affairs Manager

About the company

A distinguished global pharmaceutical company specialising in generic medicines with facilities worldwide. The company prides itself on their strong R&D focus that has resulted in an exciting product pipeline. The company also has expertise in all aspects of the drug development process from product formulation to the manufacturing of the product.

About the opportunity

As the Regulatory Affairs Manager you will be managing your own portfolio of products. The products range across all areas but will mainly consist of OTC's and generic medicines. There are products in the pipeline so this role will also focus on niche molecules and Category 1 applications when required.

Duties

• Manage all aspects of regulatory application submissions such as prescription medicines, new medicine applications and variations
• Utilise expertise to develop strategies for new product development projects
• Liaise with overseas affiliates and colleagues for regulatory matters
• Keep abreast of regulatory industry updates and advise of the impact to the company

Skills and Experience

• Bachelor's degree in a scientific related discipline
• Extensive experience in regulatory affairs for prescription medicines
• Experience liaising with TGA and Medsafe on regulatory matters
• Excellent communication skills

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.