Openings in Intas for Regulatory affairs department

 

About the Company :

Intas established and have more than 8 decades experience and is global generic company producing various pharmaceutical drugs in the areas of cardiovascular, respiratory, dermatology, pain management and so on.

The company has so many acquisitions. It have major transports to EU region . In 2018 it announces the collaboration with west Virginia university for stem educational initiatives. Firm operating globally in various countries delivering quality medicines across the globe.

About the Job : 

We at Intas Pharmaceuticals (Biopharma Division) are currently hiring for below role:

Job Title: 

Research Scientist - R&D Chemistry, Mfg. & Controls (CMC) 

Job Summary:

Carrying out CMC department related tasks especially pertaining to documentation and study co-ordinations.

Roles and Responsibilities:

Independent involvement in coordination of cross departmental / cross functional studies, data compilation, statistical analysis and evaluation- bio similarity, IRS etc.

Writing or reviewing various protocols and reports related to R&D function as per requirement (Biosimilar studies, IRS studies, CQA and QTPP documents)

Writing or reviewing SOPs and policies

Preparation of regulatory CTD sections pertaining to analytics, data collation and trending, writing responses to regulatory queries

Handling internal and external audits 

Interested candidates with 4-8 years of experience in R&D can share their CVs on [email protected]