About Role 

In this role, you'll play a key part in working alongside a dynamic team that values innovation, collaboration, and continuous growth. 

Your key responsibilities will include: 

• Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports  
• Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies 
• Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions 
• Serving as a regulatory liaison on the project team throughout the product lifecycle 
• Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC) 
• Ensuring pre-clinical and clinical trial designs meet regulatory requirements 
• Ensuring rapid and timely approval of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices 
• Serving as regulatory representative to marketing or research project teams and government regulatory agencies 
• Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations 
• Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices.

About You 

To be successful you will: 

• Managing large projects or processes with limited oversight from manager

• Coaching, reviewing and delegating work to lower level professionals

• Problems faced are difficult and often complex

Education/Qualifications 

• bachelor degree 

What You’ll Get 

At Convatec we believe in taking care of our people, because they’re the heart of everything we do. As part of our team, you’ll enjoy a range of benefits designed to support your wellbeing, growth, and success.  

These include  

• Flexible working arrangements,  

• Ongoing learning and development opportunities 

• Competitive remuneration 

• Access to health and wellbeing programs 

Ready to join us? 

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.