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GENERAL POSITION SUMMARY
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products 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 submissions. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. 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 be responsible for preparation of high quality CMC regulatory documents for the products local/global in accordance with Roche corporate standards and the requirements of applicable health authorities in support of local/global filings, and contribute to the timely regulatory approval for the local manufactured products.
?You will manage regulatory aspects of change control and ensuring 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 interact with regulatory agencies on defined matter.
?You will keep TRL (CTP, relevant stakeholders) fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
?You will contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
?You will support team leader, collaborate with the China technical partners and China Partners in PDR China to facilitate "One
Regulatory Voice" supporting assigned regulatory submissions for IND, NDA/BLA, major and/or complex variations activities across the product lifecycle portfolio.
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, Quality, R&D, and Manufacturing or related
? Experience on generating technical registration dossier for China/EU/USA is preferred.
? Analytical development, or MSAT, or manufacture process development, supply chain experience would be a plus
? Filing experience in Regulatory Affairs is a plus
Knowledge/Skills/Competencies Technical Knowledge
? Knowledge of ICH, WHO, China regulations and guidance. 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)