Regulatory Disclosure Specialist
4 weeks ago
At Roche, we're pushing back the frontiers of healthcare. Our team of over 100,000 people across 100 countries is dedicated to innovation, curiosity, and diversity. We're one of the world's leading research-focused healthcare groups, and our success is built on our ability to bring new ideas to life.
The OpportunityWe're seeking a talented Regulatory Disclosure Specialist to join our team. As a member of our Pharma Development Regulatory (PDR) Innovation and Sustainment Chapter, you'll play a key role in developing and sustaining business capabilities within PDR. Your responsibilities will include assessing processes, tools, and technology to achieve our business goals, collaborating enterprise-wide to ensure compliance, and partnering with quality organizations across PD, affiliates, Pharma, and Roche.
Key Responsibilities- Assist in posting organizational clinical trial protocols and results on public trial registration websites (ClinicalTrials.gov, EU results registry).
- Identify studies required for registry and results postings and ensure PDR management and staff are aware of timelines and requirements.
- Liaise with project teams and affiliates to ensure understanding of regulatory disclosure responsibilities.
- Submit protocol documents for registry entries and quality control checks for consistency.
- Work with cross-functional team members to gather necessary data and approvals for registry and results postings.
- Monitor workflows for timely completion of registry and results entries, ensuring uploads are done on time.
- Track and ensure timely responses to correspondence with cross-functional teams and departments.
- Degree in Life Sciences or equivalent with 1-3 years of relevant experience in the pharmaceutical/biotechnology industry, including independent project delivery and leadership of specific activities.
- Strong computer skills (Microsoft Office Suite, Adobe Acrobat), solid understanding of drug development, and familiarity with regulations and guidelines (e.g. GxP, GCP, ICH) and clinical trial disclosure.
- First exposure to regulatory affairs or product development functions.
- Strong interpersonal and communication skills, effective team member in cross-functional and matrix-based environments, with a strong sense of urgency.
- Ability to work under minimal supervision, excellent administrative and project planning skills, detail-oriented, ability to meet deadlines and work under challenging timelines. Fluency in English (verbal and written) is required.
At Roche, we offer a dynamic and supportive work environment, with opportunities for growth and development. We're committed to diversity, equity, and inclusion, and we're proud to be an equal opportunity employer. If you're passionate about making a difference in the lives of others, we encourage you to apply for this exciting opportunity.
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