Responsibilities :To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries.To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSCProcuring and legalization).To check & approve the artworks for regulated / semi regulated countries.To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission.Handling queries pertaining to regulatory submissions from various regulatory authorities.Maintain record of samples, shade cards, registration certificate etc.Desired profile of the candidate : - Should have good communication skill.Good technical knowledge, review skills, and understanding of regulatory submissions.Good leadership and organizational skills, with a strong focus on execution and follow-through.Minimum Exp. : - 8 years in Regulatory AffairsMaximum Exp. : - 15 years in Regulatory AffairsEducation : - B.Pharma / M.Pharma / B.Sc / M.Sc