Regulatory Affairs Project Manager
RocheAustria14 days ago
Full-timeQuality Assurance, Consulting
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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
At Global Regulatory Affairs, our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. The focus of our work is the global approval of in vitro diagnostics for diagnostic products. Our dynamic team manages International submissions supporting Roche affiliates around the world. Join us in an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.
We are seeking a Regulatory Manager to join our team. This role is crucial for managing the regulatory lifecycle of our products, from initial development through to market approval. You will act as a key liaison between various internal and external stakeholders, ensuring that all regulatory activities are executed efficiently and strategically.
The Opportunity
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
The Position
At Global Regulatory Affairs, our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. The focus of our work is the global approval of in vitro diagnostics for diagnostic products. Our dynamic team manages International submissions supporting Roche affiliates around the world. Join us in an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.
We are seeking a Regulatory Manager to join our team. This role is crucial for managing the regulatory lifecycle of our products, from initial development through to market approval. You will act as a key liaison between various internal and external stakeholders, ensuring that all regulatory activities are executed efficiently and strategically.
The Opportunity
- Collaborate with and manage internal and external stakeholders to drive project and product realization
- Identify and resolve regulatory issues to ensure timely completion of tasks
- Prepare and write submission packets for health authority marketing approvals
- Interpret complex regulatory frameworks to define strategies for new products and ongoing compliance
- Utilize agile principles to streamline regulatory activities
- Oversee the development of medium to high-complexity submission and product registration dossiers
- Troubleshoot and independently develop solutions for issues that arise, ensuring compliance is not jeopardized
- You have a Bachelor’s or Master's degree in Life Science, Data Science, or a related field, or have equivalent experience such as a completed technician or laboratory technician training
- You have at least 5 years of experience (with 5-10 years preferred) in Regulatory, R&D, Quality, Operations, and/or Clinical roles, with some experience in healthcare regulatory affairs
- You are able to manage high-complexity work and/or global projects with minimal supervision
- You possess a deep understanding of healthcare regulatory frameworks and are capable of working effectively with cross-functional teams to achieve common goals
- You have an agile mindset, are adept at problem-solving, and are skilled in effective communication and stakeholder management
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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