29 Oct
Lifelancer
Surat
About the JobSkillsKnowledge of regulatory requirementsFDAAttention to detailStrong communication skillsProject managementAbility to work under pressureResearch skills We are hiring forSr. Executive Regulatory Affairs. Qualification: B.pharm/M.pharm Experience 2 to 5 years only Location Sola Ahmedabad Work mode on site Role responsibilities: * Dossier preparation as per the ACTD CTD (Module I II III IV and V) guideline. * Technical documents like Raw Material and finished products specification manufacturing process * Product development report stability reports process validations preparation review. * Analytical method validation review as per the ICH guideline.
* Drug Master File review * Technical query response to the various regulatory authorities. Market ROW: Africa Latin America Eastern Europe the Middle East and parts of Asia country exposure is required. Thanks Regards Yesha (HR) Mo Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains. Please use the below Lifelancer link for job application and quicker response. Link: /jobs/view/a6aac7c0fc7bbd5b0155d7 Remote Work : No