Regulatory Labeling Manager - Flexible Working Available
At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And 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.
We currently have an opportunity for a Regulatory Labeling Manager to join our hardworking Global Product Development Regulatory Labeling team.
The Regulatory Labeling Manager leads and supports product teams on the overall development, optimization and implementation of regulatory labeling strategies and activities for the entire product life-cycle. The Regulatory Labeling department is responsible for developing and maintaining company Core Data Sheet (CDS), for medicinal products, and for guiding and supporting the implementation of CDS at country level. In addition, the department is also responsible for creating and maintaining EU and US labels throughout the product life cycle.
These responsibilities capture a portion of what your work will look like:
- Drives and optimizes the strategy for the creation and maintenance of CDS. Provide guidance and expertise to product teams on CDS supporting documents
- Authors and maintains CDS, as well as manages the CDS processes in collaboration with regulatory product responsible and product team
- Drives and optimizes the strategy for the creation and maintenance of EU and US product information package. Authors and maintains these product information documents. Leads/contributes company responses to HA questions pertaining to EU and US labeling
- Provides regulatory strategic recommendations concerning acceptable labeling in regional markets, in collaboration with the relevant functions
- Guides and supports the implementation of CDS into the Local Product Labels and manages local label deviations
- Gives specific guidance on labeling regulatory issues such as legislation, guidelines, procedures to the RAFT and Project teams
- Leads or contributes to establishment or improvement of working processes and standards
Who You Are
You’re someone who wants to influence your own development. You are looking for a company where you receive the opportunity to pursue your interests across functions and geographies. Working in a multicultural environment motivates you. As a fast learner you actively drive the quality of the requirements.
- You possess a college or university degree, preferably in science
- In-depth insight in regulatory affairs (preferably strategic labeling) and knowledge in market access is a plus
- Proven ability to lead cross-functional matrix teams with strong influencing skills
- Good interpersonal and verbal communication skills
- Ability to work effectively in a team environment and establish strong collaborative relationships
- Project management skills which allow you to consistently achieve multiple tasks and goals on-time
Occasional overseas travel may be required.
We have multiple positions open and are looking to hire in these 4 Roche locations: Basel, South San Francisco, Welwyn and Mississauga. Please inform us where you would like to be based in your application.
If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients’ lives. If you want to work in a passionate team, make your mark & improve lives, apply now.
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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