Work as Regulatory Business Integrator at Lilly - Life Sciences Apply

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Post : LRL - GRA - Regulatory Business Integrator

Key Responsibilities
• Technology Integration & Management :
- Lead the integration and configuration of Veeva RIM and other regulatory software solutions to align with business requirements.
- Utilize knowledge of Veeva Configuration, Integration to customize and optimize the use of regulatory platforms.
- Ensure seamless integration of regulatory systems with other enterprise applications, facilitating efficient data flow and process automation.
- Collaborate with IT teams to implement full-stack/veeva development projects that enhance regulatory processes.
• Regulatory Expertise:
- Provide in-depth understanding of regulatory processes such as authoring, publishing, submission, and labeling.
- Ensure compliance with regulatory requirements from FDA, EMA, Health Canada, and other global regulatory bodies.
- Stay updated on industry trends and regulatory changes to ensure systems and processes remain compliant.
• Stakeholder Management:
- Engage with business stakeholders to understand their regulatory needs and translate them into technical requirements.
- Influence and manage expectations across various departments, ensuring alignment between business goals and technology solutions.
- Serve as a liaison between regulatory affairs and IT, ensuring clear communication and effective collaboration.
• Process Improvement & Compliance:
- Identify opportunities for process improvements within regulatory operations and implement technology-driven solutions.
- Ensure all integrated systems and solutions adhere to industry standards and best practices.
- Lead training and support initiatives to ensure users are proficient in utilizing regulatory systems.

Candidate Profile
• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, or required fields
• 5+ years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
• Exposure to Veeva RIM configuration and integrations
• Experience with full-stack development and a solid understanding of the software development lifecycle (SDLC).
• Familiarity with global regulatory processes, especially those of FDA, EMA, and Health Canada.
• Experience with other regulatory software platforms and tools.
• Proven track record of leading cross-functional projects and teams in a global environment.
• Strong technical aptitude and the ability to manage complex system integrations.
• Excellent problem-solving skills and the ability to work under pressure in a dynamic environment.
• Outstanding communication and interpersonal skills, with the ability to influence and manage stakeholders effectively.

Additional Information
Experience : 5+ years
Qualification : Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Information Technology
End Date : 10th September 2024