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Die Position
POSITION SUMMARY
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.
Your Opportunity
- 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.
- You will support policy influencing and interact with regulatory agencies on defined matters, especially for segmented manufacturing.
- You will participate in the coordinating and authoring of high quality CMC regulatory regulatory documents as well as preparation of filing packages for the biologics produced in Shanghai site in accordance with Roche corporate standards and the requirements of applicable health authorities, in support of local/global SMEs, and contribute to the timely regulatory approval for the local manufactured product.
- You will keep key stake holders (incl. site MSAT, manufacturing, Quality, global regulatory, etc.) fully apprised of the pilot project status and potential submission risks and impact to defined regulatory strategies and timelines.
- You will manage regulatory aspects of change control and perform appropriate communication to stakeholders regarding management of technical changes. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.
- You will contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
- You will perform other assigned regulatory activities per demands across lifecycle management.
- You will support team leader and collaborate with the China technical partners and China Partners in PDR China to facilitateOne Regulatory Voice.
Who you are
Education
- Master’s Degree in life science disciplines is preferred
Experience
- 3 or more years’ work experience in the pharmaceutical, biotechnology or related industry in CMC, Regulatory, Manufacturing and Quality or related
- Experience on generating technical registration dossier for China/EU/USA, or MSAT / manufacturing process development experience is preferred.
- Filing experience in Regulatory Affairs is a plus
- Analytical development, or supply chain experience would be a plus
Knowledge/Skills/Competencies
Technical Knowledge
- Knowledge of ICH, WHO, China regulations and guidance (including segmented manufacturing regulations). Knowledge of regulations and guidelines of other major markets (e.g. FDA, EMA) is a plus
- Proficiency with a wide range of data/information (CMC, clinical, non-clinical)
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
