Regulatory Innovation & Sustainment Specialist - Regulatory Information Ma at F. Hoffmann-La Roche Ltd - Poland

Casco urbano de Chía, Cundinamarca, Colombia -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

0.0

Posted On

22 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Information Management, GxP, ICH, Medical Terminology, Organizational Skills, Collaboration Skills, Computer Proficiency, Continuous Improvement, Process Optimization, Data Quality, Stakeholder Engagement, Records Management, Data Reporting, Compliance Monitoring, Project Management, Subject Matter Expert

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 This is a temporary, fixed-term position for one year About Roche Product Development Regulatory Affairs (PDR): We are an agile, innovative, and collaborative regulatory organization. By leveraging strategic insights and fostering a culture of continuous learning, we work together to deliver impactful solutions that advance medical innovation. Our focus is on effectively and efficiently supporting Roche’s portfolio while creating meaningful benefits for patients and society. The Opportunity: The PD Regulatory Innovation and Sustainment Chapter drives innovation and ensures regulatory operational readiness, ensuring PDR’s readiness to operate by driving innovation, sustaining regulatory processes, and implementing continuous improvement. This role manages end-to-end processes, tools, and technologies to maintain compliance and efficiency while aligning with regulatory standards. Key Responsibilities: Actively oversee regulatory information for clinical and licensed products, ensuring accuracy and effectiveness. Partner with stakeholders to improve business processes, system performance, and data quality. Support records and information management, including during mergers, acquisitions, and archiving activities. Perform systems searches and prepare regulatory data reports to assist cross-functional teams. Lead or participate in process optimization projects and act as a Subject Matter Expert (SME) as needed. Monitor compliance by performing spot checks, data cleanups, and reporting quality metrics. Who You Are: Bachelor's Degree in Life Sciences or equivalent with 1-3 years of pharmaceutical/biotechnology industry experience. Familiarity with regulatory information management, GxP, ICH, and medical/pharmaceutical terminology. First exposure to regulatory affairs or product development functions Excellent organizational and collaboration skills with fluency in English (verbal and written). Strong computer proficiency (Microsoft Office, Google Suite, Adobe Acrobat) and ability to adapt to emerging technologies. Proven ability to work in cross-functional, matrixed environments with minimal supervision. Interest in continuous improvement and driving process efficiencies. Relocation benefits are not available for this role 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.

Responsibilities

The role involves overseeing regulatory information for clinical and licensed products while ensuring compliance and efficiency. It also includes partnering with stakeholders to improve business processes and supporting records and information management.