Regulatory Affairs Expert

4 weeks ago

New York, New York, United States Daiichi Sankyo, Inc. Full time

Global Regulatory Affairs Expert

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.

With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.

Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Key Responsibilities

  • Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, EU PL, CCDS, CCPL) for new products or products in the development phase.
  • Ensure Compliance with Core Data Sheets/Label Changes: Develops and communicates strategic labeling development strategic plan to other project team members and to cross-functional labeling review team members.
  • Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams and leads review processes to ensure appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
  • Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings and manages compliance with internal and external guidelines.
  • Establishes Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings and assists in the development of Standard Operating Procedures (SOPs) and process improvements.

Qualifications

  • Bachelor's Degree preferably in a scientific discipline required.
  • Advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred.
  • 7 or More Years pharmaceutical industry experience required.
  • 4 or More Years of direct regulatory affairs experience, including US labeling experience.
  • Experience with ex-US labeling (outside the US) preferred.

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