Position
Are you passionate about transparency and ensuring critical clinical trial data reaches the public? Join the Product Development Regulatory Affairs (PDR) Data and Content Chapter, where you will drive the strategy and execution of global regulatory disclosures. This is an opportunity to play a pivotal role in upholding Roche’s ethical commitments and shaping how patients, healthcare professionals, and the scientific community access vital clinical information.
You will ensure compliance with evolving global disclosure requirements while protecting sensitive information, contributing directly to Roche’s mission to deliver meaningful medical advances for patients worldwide.
* Ensure strategic compliance: Provide expert regulatory guidance to ensure Roche meets global disclosure requirements while safeguarding Personal Protected Data and Company Confidential Information
* Lead global trial registration: Drive the accurate and timely posting of clinical trial protocols and study results to public registries such as ClinicalTrials.gov and the EU results registry
* Enhance process excellence: Lead cross-functional initiatives to optimize information and process flow, translating business needs into efficient, globally aligned system enhancements
* Mentor and influence: Act as a Global or Business Process Owner and Subject Matter Expert, mentoring colleagues and helping to shape the internal and external environment for regulatory transparency
* Collaborate across functions: Partner with project teams, affiliates, and other cross-functional stakeholders to secure data, coordinate reviews, and ensure high-quality and consistent disclosure deliverables
* Shape regulatory transparency: Contribute to internal and external efforts to advance Roche’s leadership in regulatory transparency, maintaining awareness of emerging global requirements and trends
Qualifications
* Strong and proven experience, including several years supporting cross-functional teams in a scientific or regulatory environment
* Degree in Life Sciences or equivalent
* Demonstrated project management expertise, with exceptional attention to detail and the ability to deliver high-quality work under challenging timelines
* Proven ability to influence and collaborate effectively across global, cross-functional teams
* Excellent written and verbal communication skills, with fluency in English
* Extensive experience in regulatory affairs or other product development functions, and a deep understanding of global regulations, disclosure processes, and drug/biologics development (including GxP and GCP) is preferred
All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care.
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