Regulatory Manager : South Asia

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 of 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)