Lee Pharma Ltd Job Vacancy for MSc/ B Pharma/ M Pharma
Department: Regulatory Affairs(R.A) Designation: Chemist/ Executive
Gender: Male
Division : API
Positions : 4
Experience : 3 to 4 Yrs
Location : Hyderabad (Kazipally)
Qualification: M.sc/ B. Pharmacy/ M. Pharmacy
Key Skills
its subsidiaries / associates.
Immediate joiners preferable with reliving letter :
Managing regulatory affairs of the organization
Liaising with regulatory bodies like State and Central FDA, DCI, etc.
Well conversant with Drug law/feed supplement regulation.
Co-ordination with factory, purchase department, marketing department.
Reviewing of technical documents like process validation, method validation, stability, Spec, STP and etc.
Compilation of DMFs and handling DMF related queries. Preparation of Drug Material File
To review of documents for adequacy and accuracy.
Preparation of LOA, LOC and general documents / declarations
Hands on experience on Drafting of response to the DMF related queries and Technical queries.
Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW).
Preparation of Regulatory Amendments Variations for smooth API supplies.
Provide regulatory support to cross functional departments.
Forward your resumes to talentacquisition@leepharma.com
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