Regulatory Manager : South Asia BASF Personal Care

4.0 - 8.0 years

6 - 10 Lacs

Mumbai

Work from Office

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma in South Asia, ASEAN, ANZ Main Areas If Responsibility And Key Activities Regulatory Prepare and compile the checklist and documents for Active Ingredients, New application and renewal applications; Coordinate with global and regional regulatory on strategizing the approach for new and renewal application submission, authority deficiency questions and post approval variations Coordinate with global and regional regulatory for regulatory/quality documents support for customer requests Understand the gaps on the analytical questions from customers and provide interim or immediate support Establish an overview on upcoming and updated regulatory guidelines and identify the top focus topics for South Asia, ASEAN, ANZ Actively participate in the Regulatory process including monthly/ quarterly country calls, regional reporting and Global RA meetings Customer support Provide complete and timely support to internal and external customers on regulatory matters Industry representation Represent BASF Pharma at South Asia Pharma/Excipients associations (e-g IPEC India) Others Engage with South Asia sales head and sales colleagues to understand the business needs and potential Job Requirements Minimum Bachelor Degree in Science/ Pharmacy Minimum 5 years of regulatory and quality experience in pharmaceutical industry Understand India regulatory and US FDA guidelines Prior experiences in Regulatory Affairs/ Quality Control laboratory Team player with strong communication skills Can speak English and Hindi (preferred)

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