Regulatory Data Specialist
2 months ago
At Roche, we're committed to fostering diversity, equity, and inclusion in our pursuit of exceptional care. As a key member of our Pharma Development Regulatory team, you'll play a vital role in driving our mission forward.
The Opportunity:
- Assist in the preparation of regulatory content, ensuring alignment with applicable guidelines and Roche standards.
- Plan and create timelines for document production and review, ensuring seamless project execution.
- Review documents for organization, clarity, and scientific standards, resolving issues with cross-functional contributors.
- Manage the review and approval process, ensuring compliance with regulatory requirements.
- Collaborate with Regulatory Operations to publish documents and contribute to best practices and continuous improvement initiatives.
Requirements:
- 3+ years of experience in the pharmaceutical/biotechnology industry, with a degree in Life Sciences or equivalent.
- Proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
- Familiarity with regional/global drug development processes, regulations, and guidelines.
- Strong communication and interpersonal skills, with a strong sense of urgency.
- Ability to work with minimal supervision, with excellent administrative and project planning skills.
About Roche:
We're a research-focused healthcare group with over 100,000 people across 100 countries. Our success is built on innovation, curiosity, and diversity. Join us in shaping the future of healthcare and making a meaningful impact on people's lives.
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