Bausch & Lomb
Bausch & Lomb The Rocks NSW Australia
1 month ago
Senior Regulatory Affairs Associate
We have an exciting opportunity for a dynamic, full-time Senior Regulatory Affairs Associate to be part of the Regulatory and Medical Affairs team. We are seeking an experienced Regulatory & Medical Affairs Associate to assist with the registration of new products and the maintenance compliance of registered products.
About The Company
Bausch and Lomb is a global organisation with over 160 years of history in eye health innovation. With products available in more than 100 countries worldwide and with nearly 14,000 employees, Bausch & Lomb offer the world's most comprehensive portfolio of eye health products to consumers and eye care professionals.
About the Role
Reporting to the Regulatory & Medical Affairs Manager and working in a small team, you will be responsible for:
• Registering new medicines and new medical devices
• Maintaining compliance of registered products
• Compiling quality registration dossiers ensuring their timely... submission, and responding effectively and efficiently to Health Authorities requests
• Review and approve packaging artworks and labelling for compliance with regulations and guidelines.
• Providing accurate and timely regulatory advice to business teams
• Review promotional materials in compliance with regulations and industry Code of Conduct
• Assess Product complaints for Adverse Event reporting to Health Authorities
• Provide timely, quality medical information for medical enquiries
• Building Regulatory and Medical Affairs capabilities by assisting with the development of regulatory expertise for Regulatory Associate staff through knowledge sharing and project guidance.
To be successful in this role, you will have:
• 3 - 5 years' experience in the pharmaceutical industry with Regulatory Affairs (Essential)
• Tertiary qualifications in a pharmacy or a life science discipline (Essential)
• Knowledge of Australian and New Zealand regulatory requirements and registration processes for medicines and medical devices (Essential)
• Solid understanding of the advertising codes of practice with experience in reviewing promotional materials (Essential)
• Understanding of the new product development and commercialisation processes (Desirable).
The ideal candidate will have strong communication skills and the ability to work on multiple projects.
You will be joining an organisation with an excellent reputation, a friendly team and a very supportive culture. We offer an attractive and competitive salary, incentive bonus, and benefits including a staff eye care product scheme.
To apply, please forward an up-to-date CV and cover letter addressing the criteria.
Senior Regulatory Affairs_April 2023
The Rocks NSW Australia
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