Openings for Regulatory Affairs for Life Science / Biotechnology candidates @ Hetero Drugs
Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
Job title : Regulatory Affairs-biologics
Qualification : BSc/MSc Life Science/Biotechnology
Experience : 3-8 years
No of Openings : 3
Job Description :
One should have hands on experience on biologics/bio-similar related prodcuts.
To plan and coordinate with other supporting departments for registration of the company in respective MOH wherever applicable & to coordinate for successful cGMP inspections.
Co-ordination with cross-functional team (Plant, R&D and QA-QC Department) for preparation and receiving of Documents.
Should be well versed with dossier Compilation and submissions for Domestic, ROW, ASEAN, African, European and USA Countries.
Should be familier with regulatory Documentation like, Dossier preparation/compilation in CTD/ACTD/ANDS format, Handling documentation related to MOH Drug Registration, Regulatory strategy,Responding to queries of health authorities, Pharmaceutical product registration.
Responsible for filing applications, follow ups and obtaining permissions/licences from CDSCO.
Click here to apply
Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
Job title : Regulatory Affairs-biologics
Qualification : BSc/MSc Life Science/Biotechnology
Experience : 3-8 years
No of Openings : 3
Job Description :
One should have hands on experience on biologics/bio-similar related prodcuts.
To plan and coordinate with other supporting departments for registration of the company in respective MOH wherever applicable & to coordinate for successful cGMP inspections.
Co-ordination with cross-functional team (Plant, R&D and QA-QC Department) for preparation and receiving of Documents.
Should be well versed with dossier Compilation and submissions for Domestic, ROW, ASEAN, African, European and USA Countries.
Should be familier with regulatory Documentation like, Dossier preparation/compilation in CTD/ACTD/ANDS format, Handling documentation related to MOH Drug Registration, Regulatory strategy,Responding to queries of health authorities, Pharmaceutical product registration.
Responsible for filing applications, follow ups and obtaining permissions/licences from CDSCO.
Click here to apply
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