Regulatory Affairs Project Manager (f/m/d) – Core Reagents - 18 months temporary — 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.
Application process
- Act as a Key Interface: You will prepare and submit pre-market applications to the FDA or Notified Bodies, serving as the primary liaison to global health authorities.
- Drive Authority Interaction: You will actively interact with regulatory bodies to accelerate approvals or clearances for upcoming registrations and professionally address inquiries of all kinds.
- Ensure Portfolio Excellence: You will support product maintenance activities and continuously keep the technical documentation of our product portfolio up to date.
- Leverage International Synergies: To achieve efficient global approvals, you will collaborate closely with colleagues in Germany, Switzerland, and the US—both intra-departmentally and with global Regulatory Affairs teams, Who You Are
- You bring a sophisticated blend of scientific insights and regulatory acumen, coupled with a passion for collaborating across borders to overcome complex healthcare challenges.
- Education: A Bachelor's or Master's degree in Life Sciences, Data Science, or a related field.
- Professional Experience: A minimum of 5 years of experience within Regulatory, R&D, Quality, Operations, or Clinical environments.
- Expertise: Strong technical understanding of IVDs, combined with knowledge of international regulations governing IVD development, manufacturing, and registration (specifically EU, US, and China).
Company and context
- At Global Regulatory Affairs our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics.
- Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys Core reagent immunoassay product portfolio.
- Our dynamic team manages regulatory projects as well as overarching regulatory topics.
- Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential. The Opportunity
- Shape Strategic Direction: You will steer the strategic direction and represent the Regulatory Affairs department in international, interdisciplinary teams to foster an effective and successful working environment.
- Manage Global Product Registrations: You will manage product registrations across Europe, the United States, and China, while supporting broader worldwide registration efforts.
- Mindset & Skills: Proven track record in agile project management, exceptional self-organization, and the ability to effectively balance and prioritize multiple overlapping projects.
- Language Skills: Excellent command of English (written and spoken) for daily global collaboration; fluency in any additional language is an advantage.
- Locations: Penzberg (Germany), Mannheim (Germany) or Sant Cugat (Spain)
- At the Company's discretion, an exception to the location requirement could be made. Employment Type: Full-Time;
Additional details
- Join Roche, where every voice matters. for German version please see below
- Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.
- Leverage International Synergies: To achieve efficient global approvals, you will collaborate closely with colleagues in Germany, Switzerland, and the US—both intra-departmentally and with global Regulatory Affairs teams,
- At the Company's discretion, an exception to the location requirement could be made. Employment Type: Full-Time;
- Applications will be accepted from August 3rd to 21st. for German version please start here
Notes and original content
- Join Roche, where every voice matters.
- The Position
- for German version please see below
- The Opportunity
- Who You Are
- At the Company's discretion, an exception to the location requirement could be made.
- Employment Type: Full-Time;
- Applications will be accepted from August 3rd to 21st.
- for German version please start here
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.
