Regulatory Submission Manager - Regulatory Affairs Officer

healthsciencejobs.ch

Ectd submissions expertise
Regulatory dossier assembly and publishing
Proficiency with ms office and adobe acrobat
At Roche you can show up as yourself, embraced for the unique qualities you bring

Job Summary

  • At Roche you can show up as yourself, embraced for the unique qualities you bring.
  • This role requires solid knowledge of regulatory agency requirements for electronic submissions and practical experience in executing eCTD applications.
  • Roche empowers each other to explore new possibilities, foster creativity, and keep ambitions high to deliver life-changing healthcare solutions that make a global impact.

Matching Summary

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Skills & Requirements

Must-have

  • eCTD submissions expertise
  • regulatory dossier assembly and publishing
  • proficiency with MS Office and Adobe Acrobat
  • experience with regulatory submission software
  • project planning and execution
  • stakeholder collaboration and communication

Nice-to-have

  • experience with RIM/Veeva Vault systems
  • digital mindset and information management skills
  • continuous learning and adaptability
  • crisis management experience
  • strong interpersonal and negotiation skills
  • team collaboration and knowledge sharing

Key Requirements

  • B.S. or above in Pharmacy, Medical, Biology or related field
  • More than 3 years experience in Pharma MNCs
  • At least 2 years in regulatory submissions
  • Experience delivering eCTD submissions
  • Chinese mother-tongue level
  • English proficiency level
  • Travel frequency less than 25%

Work Rights

Not specified

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