Regulatory Specialist Diagnostics at Roche

San José, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

18 Jul, 26

Salary

0.0

Posted On

19 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory submissions, Lifecycle maintenance, Compliance, Document management, Stakeholder collaboration, In Vitro Diagnostics, Regulatory information management, Technical file maintenance, Communication, Process improvement, Self-management, Regulatory strategy

Industry

Biotechnology Research

Description

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 Position The Opportunity: As a Regulatory Specialist, you will be responsible for compiling documents and deliverables to support planned product registration timelines. You will maintain product registration throughout a product’s lifecycle by applying successful regulatory change control and ensuring alignment with local and regional registration requirements. You will work independently within guidelines and policies, acting as a resource for colleagues with less experience and providing functional guidance. Your key responsibilities will include: Submission Management: Coordinate and prepare document packages for regulatory submissions, license renewals, and annual registrations for new and mature products. Lifecycle Maintenance: Support currently marketed products regarding labeling, manufacturing changes, and technical file maintenance to ensure ongoing compliance with Global Regulatory directives. Information Systems: Maintain and create product information and reports within the Regulatory Information Management System and support documentation management workflows. Stakeholder Collaboration: Interface with internal stakeholders and external partners (Health Authorities/Notified Bodies) to promote successful registration strategies and answer submission-related inquiries. Global Support: Support international regulatory submissions by providing needed data and documents, keeping Affiliates informed of new products, projects, or process changes. Compliance & Strategy: Keep abreast of regulatory procedures and changes, recommending strategies for the earliest possible approvals of clinical trials applications and improving tracking/control systems. Who you are: You are a proactive professional with strong communication skills, a resolution-oriented mindset, and the ability to manage complex documentation in a regulated environment. Requirements and Qualifications: Education: Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, or related fields. Experience: Proven experience in Regulatory, R&D, Quality, Operations, or Clinical teams, specifically including documentation and country registration tasks. Experience with In Vitro Diagnostics (IVD) is a plus. Languages: Advanced English proficiency is a requirement. Core Competencies: * Proactive with strong self-management capabilities. Flexible, adaptable, and a curious "learning enthusiast." Process improvement oriented and able to work independently. Relocation benefits are not available for this job posting. Who we are A 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. 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. We are courageous 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 are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Regulatory Specialist is responsible for preparing and coordinating regulatory submission packages and maintaining product registrations throughout their lifecycle. They also collaborate with internal and external stakeholders to ensure compliance with global regulatory directives and support international registration strategies.