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The Opportunity:

Regulatory strategy development and implementation

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.

Managing 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.

Interact with regulatory agencies on defined matter.

Keeping TRL (CTP, relevant stakeholders) fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.

Help ensure cross-functional coordination and escalation, as needed.

Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.

Supporting departmental business processes to document and improve best practices and work efficiencies.

Supporting CMC SME 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.

Supporting CMC SME team leader, collaborate with the Regulatory Policy group, effective and timely monitoring of NMPA guidelines and trends, translating China CMC requirements into practice for global project teams, including up to date maintenance of PTR filing standards for China (Model Documents).

Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments)

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

Knowlwdge/Skills/Competencies

Technical Knowledge

Knowledge of regulations and guidelines in China and other major markets (e.g. ICH, Pharmacopoeias, NMPA, FDA, EMA, WHO).

Proficiency with a wide range of data/information (CMC, clinical, non-clinical).

Business Acumen

Knowledge of drug development, commercialization process and Pharmaceutical Quality Systems.

Knowledge of multidisciplinary functions involved in drug development (all functions) and/or manufacturing and commercialization.

Possesses strategic agility and proficiency in business tools, project management and risk- management principles.

Drives for continuous improvements and operate with lean mindset.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.