Internship - Regulatory Affairs and Quality Associate

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. Join Roche, where every voice matters.

The PositionThe OpportunityThis internship provides an exciting opportunity for recent graduates or already-qualified individuals to learn, grow, and develop during a 1-year program by being part of impactful projects that enhance patient care. You’ll have the chance to gain hands-on experience in Regulatory Affairs, learn about diagnostic solutions, and develop your technical, regulatory, and leadership skills while contributing to meaningful initiatives within one of the world's leading pharmaceutical companies.

The Regulatory Affairs intern performs the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies, SOPs, internal audits, and inspections. Compiles all materials required in submissions, license renewal, and annual registrations. Participates in the improvement of quality management system, product complaints management, and distributors quality audit. Main ResponsibilitiesAnalyze and communicate internal and external regulatory intelligenceProvide regulatory input into cross-functional Affiliate business meetingFiling:

Adapt global product dossiers to local requirements, prepare and manage regulatory registration filings and maintenance across product life cycles, monitor and communicate all regulatory filing statusPerform affiliate regulatory activities on relevant Roche systemsEnsure regulatory inspection-readiness for the AffiliateEnsure regulatory compliance for products released to market according to marketing authorizationsReview promotional and non-promotional materials to ensure compliance with regulatory guidelinesSupport continuous improvement initiatives (CAPA, audit reviews, process optimization, etc. )Monitor and support activities related to reactovigilance and materiovigilanceWho you are? Experience & Qualifications: A university degree in Pharmacy, Medicine, or a relevant biological discipline.

A Pharm D degree is preferredAt least 6 months - 1 year of professional experience in regulatory affairs, quality management, or other relevant Pharmaceutical or Biological disciplinesFluency in French is mandatoryBasic knowledge of English (written & spoken) with a strong commitment to advancing your language skillsRequired QualificationsA keen interest in learning, self-managed, proactive, and highly organizedAbility to work with cross-functional teams effectivelyDigital-savvy with the capability to understand and utilize digital toolsStrong communication skills with the ability to actively listen, inquire, and convey ideas effectivelyCritical thinking and prioritization in a VUCA (Volatility, Uncertainty, Complexity, Ambiguity) environmentWhat Will You Gain from this Internship?Comprehensive professional experience that provides solid technical and practical regulatory knowledge in in vitro diagnosticsTraining in regulatory compliance, quality management systems and soft skills to lead impactful projects and provide real value to patientsA dedicated mentor to support your development and career growth throughout your time at RocheIf you're ready to excel, make an impact, and be part of a dynamic team shaping the future of healthcare, we encourage you to apply todayWho we areA healthier future drives us to innovate.

Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.