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, ANZResponsible for all registration activities in South Asia, ASEAN, ANZ.  Consolidate and communicate prioritization of product registrations and regulatory submissionsProvide 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 environmentRegulatory 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 variationsCoordinate with global and regional regulatory for regulatory/quality documents support for customer requestsUnderstand the gaps on the analytical questions from customers and provide interim or immediate supportEstablish an overview on upcoming and updated regulatory guidelines and identify the top focus topics for South Asia, ASEAN, ANZActively 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/ PharmacyMinimum 5 years of regulatory and quality experience in pharmaceutical industryUnderstand India regulatory and US FDA guidelinesPrior experiences in Regulatory Affairs/ Quality Control laboratory Team player with strong communication skillsCan speak English and Hindi (preferred)