Manager, Technical Regulatory

About this role

<p>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.</p><h3></h3><p></p><h3>The Position</h3><p><b>POSITION SUMMARY</b></p><p>Performs end-to-end regulatory activities for biologics segmented manufacturing pilot project in China. Recommends strategies for earliest possible approvals for biologics segmented manufacturing project, based on comprehensive assessment per related regulations and specific project situations. Supports policy influencing and interacts with HA on defined matters

Coordinates and performs document authoring and prepares filing packages for regulatory submissions for biologics in Shanghai site to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in the related submissions. Recommends changes for materials, labeling, manufacturing and marketing for regulatory compliance

Monitors and improves tracking/control systems. Performs other regulatory activities per demand. Keeps abreast of regulatory procedures and changes

Works independently within guidelines and policies, receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.</p><p></p><p><b>Your Opportunity</b></p><p> You will provide recommendations on regulatory strategies for the biologics segmented manufacturing pilot project to enable earlier submission and approval, based on related regulations and specific project situations.</p><p> You will support policy influ

Apply for this role on Roche’s official careers site.