Associate Manager - CMC Regulatory

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Skills you'll use

What you'll do

• The purpose of Associate Manager, CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drug with global regulatory agencies. These roles also execute CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions.

Who can apply

• Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
• 5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management

About Elanco

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