Title:  Regulatory Intelligence Lead

Summary:

Under the leadership of the Senior Director (Head), Global Regulatory Intelligence and Policy (GRIP), partner with enterprise leadership to answer potentially sophisticated questions based on the ability to efficiently obtain, analyze, and summarize external information (notably global precedents and/or regulations) to facilitate efficient drug development and delivery.

Reporting Line: The Manager, GRIP, will have dotted line reporting to Head of CMC and Regulatory Operations, until successful hire of the Senior Director (Head) of the department.

Location: Ideally situated in India (any SUN location).

Areas of Knowledge and/or Responsibility

• Adept in interpreting regulatory queries and assimilating complex data related to regulations and drug development in one or more therapeutic areas to answer such queries
• Adept in Regulatory Intelligence systems and tools (ideally, in selecting and using advanced tools such as those with AI)
• Interacts with external and internal experts to collect country and region-specific regulatory intelligence.
• Work closely with Country SMEs contributing to the overall understanding of the local regulatory landscape.
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Education and Job Qualifications

• Expertise in interpreting regulatory queries and identifying, assimilating, and summarizing data to answer such queries
• Expertise and/or interest in building and/or selecting contemporary (ideally artificial intelligence) regulatory intelligence systems and processes
• Strong communication skills both oral and written in English
• Prefer therapeutic area knowledge in immunology (dermatology, rheumatology), gastroenterology, and/or oncology
• Advanced degree helpful (e.g., B-Pharm/MBA, M-Pharma) with 8-10 years of experience in Reg Intelligence domain