Associate Director, Labeling Expert
3 days ago
Job Summary:
Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Labeling to join our Global Regulatory Affairs team. In this role, you will be responsible for providing strategic and operational leadership on product labeling, collaborating with Global Regulatory Leads and cross-functional teams to ensure compliance with regulatory requirements.
Key Responsibilities:
- Manage multiple assigned projects of increased complexity, including post-marketing projects and those involving 3rd party development.
- Partner with Global Regulatory Leads and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products.
- Drive/lead the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.
- Ensure that draft labeling complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations.
- Interact across the RA function globally and interact across functional as well as regional areas.
Requirements:
- 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.
Travel: Ability to travel up to 10% Occasional travel.
About Daiichi Sankyo, Inc.:
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.
We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized.
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