レギュラトリーパブリッシング/ Regulatory Publishing

A global life sciences consulting company is looking for a Regulatory Publishing Senior Specialist. The selected candidate will lead regulatory submission publishing activities while ensuring technical accuracy and compliance with health authority standards.

Responsibilities:

• Lead production of high-quality eCTD/Nees/Paper submissions in collaboration with submission managers
• Ensure submission integrity aligns with internal and external regulatory requirements
• Train and mentor internal and external publishing staff
• Coordinate timelines and requirements to execute right-first-time submissions
• Identify and escalate risks or issues affecting submission success
• Track project status, daily activities, and publishing anomalies
• Provide administrative support for publishing functions
• Develop and maintain publishing processes and documentation
• Act as a subject matter expert and guide stakeholders
• Evaluate and improve publishing processes and tools

Requirements:

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Sciences, Medical or a related scientific discipline
• Practical experience in regulatory publication or submission
• Prior experience in project management
• Knowledge of PMDA
• Skilled in electronic document management systems

About the Company:

A global leader in life sciences consulting, this company delivers regulatory, clinical, and quality solutions to support pharmaceutical, biotechnology, and medical device companies worldwide. Known for its innovative approach and deep domain expertise, it empowers job hunters to be part of impactful projects that advance healthcare and compliance on a global scale.

Keywords:

規制申請, 出版業務, 製薬業界, ドキュメント管理, トレーニングと指導, 求人, 外資系

Job Ref: W0PWG3