International Regulatory Coordinator

Job Description of Regulatory Project Management Candidate :

• The primary responsibilities will involve supporting Regulatory Affairs (RA) activities
• Arranging the Legal Documents (POAs, LOAs) and Apostillizations & Sending hard copies to country teams.
• Arranging Admin documents (GMP,COPP & FSC) and Apostillizations & sending hard copies to country teams (Co-ordination with HO team).
• Arranging the Technical documents like Qualitative & Quantitively (Q&Q documents) with co-ordination of RA team and getting them Apostilled and sending the hard copies to Country teams.
• Co-Ordinating with Legal teams, SCM(Ref stds / RLDs) and IT(Zoho aspects) teams to extend the support from HO to countries.
• Co-Ordinating with Marketing / Regulatory service providers based at Latin America in regulatory support aspects from HO.
• Co-Ordinating with IP teams based at R&D in patient related aspects in Emerging markets countries & Co-ordination with Portfolio teams at HO in PEF & PIF aspects.
• Co-Ordination with R&D PM team's in DPDM&CDP analysis and arranging the required support from HO.
• Arranging the FP samples from Plants and other required documents to Countries for Dossier Submissions.
• Arranging the Analytical Pre-Requisites to Countries as per the requirement by Coordinating with Plant QC / QA.