Associate Manager - CMC Regulatory
BengaluruFull-time3–5 yrsPosted 2 days ago
Mid-level legal role at PL02 Elanco Solution Center in Bengaluru. Needs 3–5 years and an M.Sc, B.Pharm or M.Pharm.
About the role
Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!
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
- These roles also execute CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products
- Proven track record of overseeing end to end Life cycle management (LCM) of Small and/or Large Molecules/Complex dosage forms/Sterile preparations/Products derived from…
- Design/develop CMC regulatory strategy for marketed products with a focus on creativity and innovation
- Maintain a positive collaboration and partnership with internal groups in R&D, Quality, Manufacturing and with global regulatory business partners of Elanco
What you need
- Compliance
- Documentation
- GMP
Good to have
- Regulatory affairs