Regulatory Affairs Lead

Roche

5 years pharmaceutical regulatory experience
Malaysia pharmacy degree and license
Gmp and gdp training knowledge
This senior role involves setting strategy, allocating resources, and providing mentorship to the Regulatory Affairs team

Job Summary

  • This senior role involves setting strategy, allocating resources, and providing mentorship to the Regulatory Affairs team.
  • The position requires leading pre-launch registration strategies and ensuring compliance with local Malaysian regulations and Roche global standards.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters in the mission to prevent, stop, and cure diseases.

Matching Summary

This senior role involves setting strategy, allocating resources, and providing mentorship to the Regulatory Affairs team.

Skills & Requirements

Must-have

  • 5 years pharmaceutical regulatory experience
  • Malaysia pharmacy degree and license
  • GMP and GDP training knowledge
  • Fluent in English and Bahasa Malaysia

Nice-to-have

  • Experience shaping regulatory policies
  • Team coaching and mentorship skills
  • Process optimization expertise
  • Strong internal stakeholder relationships

Key Requirements

  • Minimum 5 years regulatory affairs experience
  • Degree in Pharmacy accredited by Ministry of Health Malaysia
  • Eligible for necessary pharmaceutical licenses in Malaysia
  • Proficiency in GMP and GDP requirements

Work Rights

Must hold valid Malaysian pharmacy license

Tailored Resume

Cover Letter