Regulatory Affairs Project Manager (m/f/d) — Roche
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
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.
Company and context
- At Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics.
- The focus of our work in the Subchapter Cardiology, Endocrinology and Fertility is the global approval of in-vitro-diagnostics of the Elecsys and Point of Care solutions product portfolio.
- Our team is tasked with regulatory projects as well as overarching regulatory topics.
- You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.
- In this role, your main purpose and tasks will be the following:
- Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams in order to create an impactful and fruitful work environment.
- Manage cardiology, endocrinology, women’s health or critical care product registrations in Europe, United States and China and support worldwide registrations
- Prepare and submit premarket submissions to FDA or Notified body serving as the primary interface to Health authorities.
- Interact with regulatory agency personnel in order to expedite approval or clearance of pending registration and answers any questions
- Be accountable for supporting product care activities and updating the technical documentations of the product portfolio.
Additional details
- Join Roche, where every voice matters.
- At the Company's discretion, an exception to the location requirement could be made.
- In order to achieve efficient approvals worldwide, you work in close collaboration with colleagues in Germany, Switzerland and the US within and across chapters as well as with global Regulatory Affairs teams, especially in China and Japan. What you should have in your toolbox: High degree of subject matter expertise:
- You are able to make decisions to complete daily scheduled and unscheduled activities and initiate interactions across departments as applicable. You have courage to make decisi
Notes and original content
- The Position
- Who We Are
- In order to achieve efficient approvals worldwide, you work in close collaboration with colleagues in Germany, Switzerland and the US within and across chapters as well as with global Regulatory Affairs teams, especially in China and Japan.
- What you should have in your toolbox:
- High degree of subject matter expertise:
- You are able to make decisions to complete daily scheduled and unscheduled activities and initiate interactions across departments as applicable.
- You have courage to make decisi
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.
