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.
The Position
JOB DESCRIPTION – primary duties and responsibilities
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)
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
Knowledge/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.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.