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 PositionJOB DESCRIPTION – primary duties and responsibilitiesRegulatory 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)
- QUALIFICATIONSEducation
- 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/CompetenciesTechnical 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.
Skills Required
- Three or more years of experience in pharmaceutical, biotechnology, or related industries, including CMC, Regulatory, Quality, R&D, or Manufacturing
- Knowledge of regulations and guidelines in China and major markets, including ICH, Pharmacopoeias, NMPA, FDA, EMA, and WHO
- Proficiency working with CMC, clinical, and non-clinical data and information
- Knowledge of drug development, commercialization processes, and Pharmaceutical Quality Systems
- Master's degree in a life science discipline
- Experience generating technical registration dossiers for China, the EU, or the USA
- Experience in analytical development, MSAT, manufacturing process development, or supply chain
- Regulatory Affairs filing experience
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
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Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
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Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
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Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
