Regulatory Affiars

Requirements

1. Educational Background

• Bachelor’s degree or higher in pharmacy, life sciences, medicine, or a related field
  




• Advanced degrees (MSc, PharmD, PhD) are a plus
  

2. Experience

• 3–5+ years of experience in regulatory affairs within the pharmaceutical, biotech, or medical device industry
  




• Experience with Japan’s PMDA processes (for Japan-based roles)
  




• Prior involvement in new drug applications (NDAs), clinical trial notifications (CTNs), or post-marketing submissions
  

3. Knowledge & Skills

• Strong understanding of regulatory guidelines (e.g., ICH, GxP, Japanese Pharmaceutical Affairs Law)
  




• Familiarity with local and global regulatory frameworks (PMDA, FDA, EMA etc.)
  




• Ability to prepare and review regulatory documents and submissions
  




• Detail-oriented with strong project management skills
  




• Understanding of drug development and lifecycle management
  

4. Communication & Collaboration

• Effective communication skills for interactions with regulatory authorities and cross-functional teams
  




• Strong writing ability for dossier preparation and regulatory correspondence
  




• Ability to work in a matrix environment with R&D, clinical, quality, and commercial teams
  

5. Language

• Proficiency in Japanese (native level) and English (business level), especially for global companies or local-global interactions
  

6. Certifications (Optional but Preferred)

• RAC (Regulatory Affairs Certification)
  




• Relevant training in GCP, GMP, or GLP regulations