The Associate/Senior Associate position at Lilly in Bangalore, Karnataka, focuses on leading and managing the global marketing authorization submission processes within the Global CMC Regulatory Affairs (GRA) team. The role involves collaboration with GRA-CMC RA Scientists to manage submission content, assist with Ministry of Health responses, and ensure compliance with regulatory standards.
Key Responsibilities:
- Regulatory & Drug Development Expertise:
- Lead the CMC submission management process, ensuring compliance with global regulatory requirements.
- Partner with CMC RA Scientists to plan and prepare submission content for clinical studies and manufacturing changes.
- Manage communication between Lilly affiliates, GRA-CMC Scientists, and other internal teams.
- Leadership & Collaboration:
- Foster an open environment within the Global Regulatory Area for discussion and decision-making.
- Communicate effectively to guide life-cycle management processes.
- Demonstrate strong problem-solving and regulatory issue resolution skills across functions and geographies.
Qualifications:
- Education: Bachelor’s degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry).
- Experience: Preferred experience in pharmaceutical drug development or industry-related roles.
- Skills: Strong written, spoken, and presentation skills, attention to detail, effective teamwork, and the ability to operate in a regulated environment.
