【alexion Japan】senior (labeling) Manager Regulatory

Alexion

Japan
Japanese package inserts (jpis)
Regulatory authority relations
Product development lifecycle management
Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials

Job Summary

  • Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials.
  • The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and performing pharmaceutical tasks required for product development and life cycle management in a timely and appropriate manner.
  • Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

Matching Summary

Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials.

Skills & Requirements

Must-have

  • Japanese Package Inserts (JPIs)
  • Regulatory authority relations
  • Product development lifecycle management
  • Promotional material review
  • e-labeling PDF and XML creation

Nice-to-have

  • Fostering a culture of belonging
  • Commitment to diversity and inclusion
  • Providing reasonable accommodations

Key Requirements

  • More than 3 years’ experiences of JPI
  • BA/BS degree in life sciences

Work Rights

Not specified

Tailored Resume

Cover Letter