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Associate Director, Global Regulatory Affairs Labeling Expert
2 months ago
About the Role:
Daiichi Sankyo, Inc. is seeking an experienced Associate Director to lead our Global Regulatory Affairs Labeling team. As a key member of our Regulatory Affairs function, you will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).
Key Responsibilities:
- Act as the point of contact for cross-functional teams on global labeling issues, ensuring compliance with all applicable regulations and guidelines.
- Manage updates to Core Data Sheets for assigned products, ensuring implementation of CCDS/labeling agreements with licensing partners.
- Conduct Label Review Committee Meetings, preparing documents for review by labeling teams and ensuring appropriate governance for US, EU, and Company Core documents.
- Establish processes and best practices for labeling, reinforcing best practices at cross-functional meetings and assisting in the development of Standard Operating Procedures (SOPs) and process improvements.
- Build cross-functional and cross-regional relationships, collaborating with Global Labeling Operations and Compliance Leads to produce high-quality labeling documentation.
Requirements:
- Bachelor's Degree in a scientific discipline required; advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred.
- 7 or more years of pharmaceutical industry experience required, with 4 or more years of direct regulatory affairs experience, including US labeling experience.
- Experience with ex-US labeling (outside the US) preferred.
What We Offer:
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
