Senior Regulatory Affairs Manager (m/w/d) — Roche
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
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.
- Key Responsibilities
- As an International Regulatory Affairs Professional at Roche, you will be responsible for:
Main responsibilities
- Key Responsibilities
- As an International Regulatory Affairs Professional at Roche, you will be responsible for:
- Leading and supporting regulatory strategies for global IVD/MD instruments & software submissions especially in the cross customer area laboratory automation environment
- Ensuring compliance with international regulatory requirements and standards
- Collaborating with cross-functional teams, including R&D, Quality, and Clinical, to drive regulatory initiatives
- Providing regulatory guidance to support product development and lifecycle management
- Staying abreast of evolving regulatory trends and up‐ dates, and implementing best practices Requirements
- Bachelor’s Degree in Life Sciences, Regulatory Affairs, or a related field
- 5 to 10 years of experience in Regulatory Affairs ( Regulatory, R&D, Quality and/or Clinical), with some experience in healthcare regulatory affairs
- In-depth knowledge of global regulatory requirements, guidelines, and procedures especially for IVD instruments & software
Application process
- We look forward to receiving your application! for German version please start here Dein neues Team
- Roche sucht eine dynamische und hochmotivierte Persönlichkeit zur Unterstützung unseres Teams als International Regulatory Affairs Professional.
- Wir suchen Dich mit einer Denkweise geprägt von Mut zu Innovation und Kreativität sowie einer nachgewiesene Erfolgsbilanz im Bereich Regulatory Affairs.
- Wenn es Deine Leidenschaft ist, durch exzellente regulatorische Arbeit einen positiven Beitrag zur globalen Gesundheitsversorgung zu leisten, laden wir Dich herzlich dazu ein, Teil unseres engagierten Teams zu werden. Verantwortlichkeiten
- Du leitest und unterstützt regulatorische Strategien für globale IVD/MD-Instrumenten- &
- Software-Zulassungen, insbesondere im Bereich der laborübergreifenden Automatisierung.
- Du verantwortest die Sicherstellung der Einhaltung internationaler regulatorischer Anforderungen und Standards.
- Vertrauensvoll legen wir die Zusammenarbeit mit funktionsübergreifenden Teams (wie F&E, Qualität und Klinische Forschung) in deine Hände, um regulatorische Initiativen voranzutreiben.
Company and context
- Strong organizational and communication skills
- Ability to multitask and effectively manage multiple projects simultaneously
- Self-motivated and capable of working independently in a self-management environment
- Experience in IVD instrument and/or software development ideally in the Laboratory Automation space.
Additional details
- Join Roche, where every voice matters. for German version please see below
- Staying abreast of evolving regulatory trends and up‐ dates, and implementing best practices
- We look forward to receiving your application! for German version please start here
- Wenn es Deine Leidenschaft ist, durch exzellente regulatorische Arbeit einen positiven Beitrag zur globalen Gesundheitsversorgung zu leisten, laden wir Dich herzlich dazu ein, Teil unseres engagierten Teams zu werden. Verantwortlichkeiten
- Du beobachtest kontinuierlich regulatorische Trends und Updates sowie die Implementierung von Best Practices. Das bringst Du mit
- 5 bis 10 Jahre Berufserfahrung im Bereich Regulatory Affairs (Regulatorik, F&E, Qualität und/oder Klinische Forschung), idealerweise mit erster Erfahrung im Gesundheitswesen.
Notes and original content
- Join Roche, where every voice matters.
- The Position
- for German version please see below
- Your new team
- Requirements
- We look forward to receiving your application!
- for German version please start here
- Dein neues Team
- Wenn es Deine Leidenschaft ist, durch exzellente regulatorische Arbeit einen positiven Beitrag zur globalen Gesundheitsversorgung zu leisten, laden wir Dich herzlich dazu ein, Teil unseres engagierten Teams zu werden.
- Verantwortlichkeiten
Questions about this listing
What salary does Roche offer for this role?
Roche lists CHF 85'500 - 129'500 gross per year for this position in Basel. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
