Specialist

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

QUALIFICATIONS

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

JOB DESCRIPTION – primary duties and responsibilities

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

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)

Who we are

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.