Lee Pharma Ltd, An ISO 9001:2000&WHO GMP Certified, One of the Best and Largest Manufacturers of Bulk Drugs & Intermediates in India. It is a Joint Venture with a renowed MNC having strong focus on Exports. We believe in quality, result of persistent efforts. Lee Pharma Ltd – Immediate Hiring For Research Associate – II – Formulation R&D for Visakhapatnam Location.
We have urgent Vacancy in LEE PHARMA LTD
- 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
- Immediate joiners preferable with reliving letter
Key Skills : =) Managing regulatory affairs of the organization its subsidiaries / associates.
=)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.
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