About Company:
Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
Website
http://vbshilpa.com
Vacancy Details:
Job Description:
Requirement of Senior Manager/ Team Lead US/EU – Regulatory affairs – Formulations for Shilpa Medicare Limited, Hyderabad.
Experience: 10- 15 Years
Designation: Senior Manager/ Team Lead US/EU
Department: Regulatory affairs – Formulations
Job Location: Nacharam, Hyderabad
Education: M. Pharm, B Pharm
Please share your CV to karthik.kumar@vbshilpa.com
Key Responsibilities:
Should handle a team of 4-10 members.
1.Must have experience into formulations US – ANDA/NDA and EU Generic/Hybrid applications.
2.Should be familiar with oral solids and parenteral dosage forms.
3.Should familiar with pre and post approval regulatory activities.
4.Should handle the customer and Agency queries.
5.Should handle other regulatory activities based on organization need.
6.Should support plant RA activities and other CFTs as needed.
Please share your CV to karthik.kumar@vbshilpa.com
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