Regulatory Affairs Manager — Roche
NewCHF 68'000 - 103'000
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 68'000 - 103'000
Role overview
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.
- 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.
- You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
- You contribute to audits by supporting preparation, execution and follow up.
- Opportunità
- You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs.
Main responsibilities
- You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
- You contribute to audits by supporting preparation, execution and follow up.
What the company offers
- Opportunità
- You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs.
- You develop and manage parts of comprehensive global regulatory submissions and registration plans.
- Specifically, you bring knowledge of USFDA regulations including Research Use Only (RUO) and IVD marketing pathways.
- You interface with external management.
Application process
- You build effective and enduring external relationships and apply effective stakeholder management practices.
- You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance.
Company and context
- At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics.
- Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in systems and software including hardware-software instrument systems.
- This role will specifically support our Sequencing portfolio in our Molecular Customer Area.
- You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.
- You lead the organization to adapt to the evolving regulatory environment and requirements.
- You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making.
- You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.
- You effectively partner with end influence stakeholders to understand and provide best solutions.
- You take initiative to address problems or opportunities and involve collaborators for best solutions.
- You develop relationships that significantly influence the current and future direction for Roche and our products.
Additional details
- Join Roche, where every voice matters. A healthier future.
- You bring out the best in people and teams.
Notes and original content
- Descrizione
- Join Roche, where every voice matters.
- The Position
- A healthier future.
