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.

Relocation benefits are not available for this job posting.

Job Summary

The Systems and Regulatory Specialist is a hybrid role between SMG/TechReg. This role is an Individual Contributor that works cross functionally with multiple Regulatory Departments such as PTR & PDR to deliver high-quality regulatory support on the multiple platforms & Submissions. Ensure regulatory information in systems is accurate, complete, and relevant to the different needs of our stakeholders. Actively participate in submission, OCM meetings and initiatives by providing input on future system enhancements and business process improvements.

The Opportunity:
Business Systems:

Meeting participation with different platform owners and regions across the globe (EMEA, APAC, NALA).

Direct support and initial point of contact for tools such as but not limited to RIM, IDM, VPH, Onstyle, Q&A Interface, and platforms considered within the PTR Digital Transformation.

Plan/Track/Register & Author/Approve/Collaboration support for Vault RIM users (HQ and Affiliates).

Provide support to post-training for new business users, such as answering simple questions and escalating as needed.

Participate in informal testing of new tools or new features of existing tools.

Request/set up access for users to the mentioned system tools.

Understand business impact of downtimes, maintenance, updates and similar changes related to system tools of the PTR department.

Documentation of Incidents and Tasks on the ServiceNow platform.

Ownership, follow up and resolution of the Incidents/Tasks.

Cross-collaboration with other PTR staff via gSuite and ServiceNow.

Submission Management Group:

Prepare and update technical regulatory documents (Word and PDF) according to requirements provided and ensure adherence to applicable regulatory requirements (e.g., CTD) and Roche CMC documentation standards.

Format detailed data tables and figures and apply document formats using customized Word templates to both Spanish and English documents.

Maintain regulatory documents and records in document management systems (e.g., RIM).

Plan and coordinate the required operational activities with respect to correct data entry and adherence to the timelines provided (e.g. RIM, request forms).

Compile regulatory dossiers, format them for publishing and dispatch within the regulatory system.

Participate in SMG initiatives.

Who you are:

Ideally, an individual will have at least 2-3 years of related experience in a similar role. Or minimum BA or BS (or equivalent) degree in English, biology, chemistry, pharmacy, or informatics with some science background

Previous experience with regulatory data, documents and dossier structures (e.g., CTD) or in the biotech or pharmaceutical industry would be beneficial, but is not required.

Fluent English speaker.

Proactive and self study capabilities.

Resolution oriented.

Flexible and adaptable to unexpected changes with short response time.

Data literacy: comfort in working with data and knowledge of applications in a computerized environment, including spreadsheets, applications, and databases (e.g. Excel, PowerPoint, Word, G-Suite, etc.)

Leadership skills.

Customer service skills required.

Analytical and presentation skills.

Crossed collaboration attitude.

Quality-Resolution oriented.

Strong Communication skills.

Working in a global environment within agile teams.

Strong organizational and time-management skills

Please note: Resumes must be submitted in English, as our interview panel may include participants from outside your local country.

#LI-DC1

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.