FUSION - Senior Regulatory Affairs Manager

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

In this role, your main purpose and tasks will be the following:

• Obtain Regulatory approvals in defined markets in close cooperation with other functions for the respective area of responsibility.

• Will develop complex regulatory strategies for very complex projects and technologies.

• Oversee Communication plans to various Health Authorities are developed with appropriate stakeholders.

• Maintain the obtained Regulatory approvals/ permits/licenses products throughout the life cycle of the product by applying successful Regulatory change controls.

• Ensure the efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc).

• Ensure the regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.

• Ensure he activities are driven by a mindset of innovation, agility and the principles of VACC leadership.

​About the role:

Duties will include, but are not limited to:

• Regulatory document and submission compilation: Oversees the development of submission/product registration dossiers of the most complex products/programs. Develops and manages comprehensive global regulatory submissions and registration plans. Mentors more junior team members in this area. 

• External interface management:  Leads external complex initiatives including the collaboration with key stakeholders. Cultivates and utilizes external relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Develops/maintains health authority relationships and actively shapes the regulatory environment. Has the ability to represent Roche in audits and other complex stakeholder negotiations. 

•  Regulatory knowledge and strategy:  Lead the organization adapt to evolving regulatory environment and requirements. Experience in solving complex, critical health authority issues or equivalent understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. 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. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.

• Stakeholder management and influencing: Leads complex initiatives including collaboration with key stakeholders. Cultivates and utilizes relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Ability to shift the perspectives of key stakeholders to achieve a specified goal. Builds common ground and alignment even if initial positions were far apart. Negotiates to maximize value for Roche and stakeholders so we have biggest impact for customers and patients. 

• Decision making: Has courage to make decisions even outside of scope/comfort zone. Proactively initiates activities independently and initiates interactions across departments as applicable. Embrace the good decision making principles. Pushes decision making to the lowest appropriate level. Commits to decisions that have been made. Shows good judgment in decision making. Makes good decisions without necessarily having all the information in a timely manner. 

• Innovation and problem solving:  A mindset of cr