Regulatory Affairs Manager, Companion Diagnostics
About The Position
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 Companion Diagnostics. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties. A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
Requirements
- Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
- 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs.
- Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
- Demonstrated ability to manage more complex work and/or at parts of global projects.
Nice To Haves
- Advanced degree preferred.
- Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
Responsibilities
- Oversee regulatory document and submission compilation, including the development of submission/product registration dossiers of more complex products/programs.
- Develop and manage parts of comprehensive global regulatory submissions and registration plans.
- Interface with external management, understanding their structure, key roles, and responsibilities, and communicating timely and effectively the needs of external customers/stakeholders.
- Build effective and enduring external relationships and apply effective stakeholder management practices.
- Contribute to audits by supporting preparation, execution, and follow-up.
- Lead the organization to adapt to the evolving regulatory environment and requirements.
- Understand external environmental changes and precedents to navigate complex situations and influence strategies and decision-making.
- Interpret and apply understanding of regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance.
- Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
- Effectively partner with external and internal stakeholders to understand and provide best solutions.
- Take initiative to address problems or opportunities and involve collaborators for best solutions.
- Develop relationships that significantly influence the current and future direction for Roche and our products.
- Make decisions even outside of scope/comfort zone and proactively initiate activities independently.
- Embrace good decision-making principles.
- Model VAAC Leadership and agility.
- Identify opportunities to develop VACC competency.
- Act with integrity, courage, passion, and honor commitments.
- Contribute to an inclusive environment.
- Pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes.
- Address and resolve conflict by creating an atmosphere of openness and trust.
- Bring out the best in people and teams.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
