Director, Global Regulatory Affairs, Growth Markets

Director, Global Regulatory Affairs for Growth Markets

Eisai is seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

• Provide strategic leadership in developing registration life-cycle management of products
• Ensure that regulatory strategies align with business objectives and comply with local regulations
• Develop implement lifecycle management activities across growth markets including Latin America Africa Middle East Asia regions reviewing guidance creating technical files preparing NDA/MAA submissions coordinating timelines budgeting tasks monitoring project performance assessing program risks ensuring adherence organizational procedures protocols satisfactory performance goal results managing quality interacting vendors clients receiving resolving submitting new good docs compliance enforcing enforcing grace periods assisting as assigned resultant productive overall yields innovative.