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Job Location | Chennai |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Recruitment Services |
Functional Area | Operations Management / Process Analysis |
EmploymentType | Full-time |
expert_license management in chennai**Job Specific Competencies & Skills:** * Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations * Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset) * Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally * Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtOs, AFs, CLs, PoAs etc.) as well as legalization framework * Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request * Adherence to agreed timelines and proactive communication of any potential risk to the same * Project management and documentation skills, proactive communication approach * Contributor level of experience with RIM and EDMS RA applications * Excellent written and spoken English language skillsRIMS,
Keyskills :
regulatory affairsregulatory documentationlcmregulatorymanagementmilestonesenglishgmpriskspoken englishadherenceafsregulatory guidelinesproject managementedmsinterpretstatements of work sowrim