Regulatory Data Specialist

2 months ago


Mississauga, Ontario, Canada Roche Full time
Unlock Your Potential in Regulatory Data

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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