Regulatory Affairs Lead

Roche

Subang Jaya, Malaysia
Not specified
Minimum 5 years regulatory affairs experience
Degree in pharmacy accredited by malaysia ministry of health
Knowledge of malaysian pharmaceutical regulations
Roche is seeking a Regulatory Affairs Lead to oversee and manage regulatory strategies and compliance within its Subang Jaya, Malaysia affiliate. The ideal candidate will have at least five years of experience in regulatory affairs, specifically within the pharmaceutical sector, and will be responsible for engaging with health authorities, optimizing regulatory processes, and leading a team

Job Summary

  • This senior role involves setting strategy, allocating resources, and providing coaching for the Regulatory Affairs team at Roche.
  • The position requires leading strategic oversight of all regulatory filing activities across product life cycles to ensure timely approvals.
  • Candidates must possess a pharmacy degree accredited by the Ministry of Health in Malaysia and have at least five years of relevant experience.

Matching Summary

Match Score: 85

Roche is seeking a Regulatory Affairs Lead to oversee and manage regulatory strategies and compliance within its Subang Jaya, Malaysia affiliate. The ideal candidate will have at least five years of experience in regulatory affairs, specifically within the pharmaceutical sector, and will be responsible for engaging with health authorities, optimizing regulatory processes, and leading a team.

Skills & Requirements

Must-have

  • Minimum 5 years regulatory affairs experience
  • Degree in Pharmacy accredited by Malaysia Ministry of Health
  • Knowledge of Malaysian pharmaceutical regulations
  • Fluency in English and Bahasa Malaysia
  • GMP and GDP training

Nice-to-have

  • Experience leading team strategy and mentorship
  • Ability to shape regulatory policies with government bodies
  • Strong stakeholder negotiation skills
  • Commitment to continuous process optimization

Key Requirements

  • 5+ years in pharmaceutical regulatory affairs
  • Accredited Pharmacy Degree from Malaysia
  • Valid pharmaceutical license eligibility
  • Proficiency in GMP and GDP standards

Work Rights

Must hold necessary pharmaceutical licenses in Malaysia

Tailored Resume

Cover Letter