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Roche Diagnostics Int. AG
2mo ago

Regulatory Affairs Project Manager(m/w/x)

Risch-Rotkreuz
Full-timeOn-siteSenior
Data Science

Description

In this role, you will navigate the regulatory lifecycle of products while collaborating with diverse teams to ensure efficient approvals. Your daily responsibilities will include preparing submission packets, resolving regulatory challenges, and developing strategies for compliance.

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Requirements

  • Bachelor’s or Master’s degree in Life Science, Data Science, or related field, or equivalent experience
  • At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical roles
  • Ability to manage high-complexity work and/or global projects with minimal supervision
  • Deep understanding of healthcare regulatory frameworks
  • Agile mindset, adept at problem-solving, and skilled in effective communication and stakeholder management

Education

Bachelor's degree
OR
Master's degree
OR
Vocational certification

Work Experience

5 - 10 years

Tasks

  • Collaborate with internal and external stakeholders
  • Manage project and product realization
  • Identify and resolve regulatory issues
  • Prepare submission packets for marketing approvals
  • Interpret regulatory frameworks for strategy development
  • Utilize agile principles to streamline activities
  • Oversee development of submission and registration dossiers
  • Troubleshoot and develop solutions for compliance issues

Languages

EnglishBusiness Fluent

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