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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Dear All,Greeting from Hetero Biopharma.We have an opening for Regulatory Affairs PositionDepartment: Regulatory AffairsDesignation: Sr.Executive /Asst.ManagerExperience: 4 Yrs. to 8 Yrs.Job Location: Jadcherla(Telangana)Job Responsibilities1. To verify the country specific guidelines, evaluate & submit the dossiers as per the client/MOH requirements. 2. To prepare the dossiers (eCTD, CTD & country specific format) that review, organization for AFRICAN, CIS, LATAM and MENA region countries. 3. Receipt and submission of responses to the queries of dossier of data packages submitted to AFRICAN, CIS, LATAM and MENA countries. 4. To co-ordinate with cross functional teams to initiate the new studies for suffice the query response & dossier requirement towards country specific requirements for product registration. 5. To prepare & submission of post approval changes (PAC) in accordance with country specific variation guidelines & get the approvals. 6. Keeping abreast with updating of country specific regulations and guidance. 7. To co-ordinate with CFTs for preparation of Master Artworks.Interested Candidates share profile to edukondalu.m@heterodrugs.com,
Keyskills :
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