Direct Materials Regulatory Filings Expert

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.

At Roche we believe that every patient deserves access to life-changing innovations. As a global healthcare leader operating across pharmaceuticals and diagnostics we combine cutting-edge science advanced technology and a passion for improving lives to address some of the worlds most challenging medical needs. Driven by our commitment to research and sustainable healthcare solutions we foster an inclusive collaborative environment where diverse teams are empowered to question the status quo drive continuous improvement and redefine what is possible in modern medicine.

The Pharma Technical (PT) Operations Global MSAT & Engineering group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow while standardizing and driving operational excellence in PT today.

The PTT Direct Materials Certification and Filing Expert reporting to the PTT Direct Materials Certification and Filing Team Lead is responsible for providing technical oversight and proactively implementing solutions supporting Direct Materials and distribution networks. The position is accountable for the various filing requirements and appropriate certification of our products including oversight of current Health Authority regulations regarding biological-derived materials. This role requires innovative efficient and sustainable technical solutions to ensure a robust and flexible supply chain and deliver processes that enable distribution of healthy products across the product life cycle.

The Oppurtunity

• Accountable for the design and robust execution of the Certification and Filings business process and oversight of content for Biologics and Synthetic Molecules (e.g. BSE/TSE GMO virus-risk).
• Accountable for proactive management of Direct Materials Filing Strategies in alignment with PTR to ensure compliance with relevant Health Authority requirements.
• Accountable for building collaborations and work relationships between key stakeholders and user groups including External Quality Procurement Planning QC QA Manufacturing Development and Regulatory.
• Responsible for authoring reviewing and/or approving Certificates and Filing sections with legalization signature responsibilities for Roche products.
• Maintains a state of global inspection readiness at all times and is responsible for implementing compendia changes and/or changes related to Health Authority audits.
• Responsible for owning and/or assessing information requests related to material topics to support Product Health.
• Lead Direct Material Management data improvement activities driving successful implementation of programs including data management systems understanding and process design.

Who you are:

• Experience & Education: BS/MS/PhD in Science Engineering or Management with at least 5 years of experience in the pharmaceutical pharmaceutical or medical device industry. Experience in regulatory filings and/or material specifications is an advantage.
• E2E Thinking: Experience working in/leading teams in a global setting.
• Technical Expertise: Must possess advanced project management skills with working knowledge of ICH guidelines ISO standards Pharma GMP operations and Health Authorities regulations. Knowledge of Quality Systems (CAPA Change Management) and Operational Excellence tools (Six Sigma Lean) is desired.
• Strategic E2E Thinker: Ability to align with matrix leadership model combining strategic clarity with innovative and coaching capabilities.
• Outstanding Communicator and Influencer: Ability to build connections encourage feedback and foster a collaborative environment with an understanding of business needs.
• Inclusive and Open Minded: Committed to creating an inclusive environment where team members feel safe valued and empowered to perform their best.
• Travel: <10% of travel required.

**Relocation is not offered for this position**

We use artificial intelligence to screen assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.