Our goal at Lilly is to improve people’s lives globally by fusing compassion and research. With our headquarters located in Indianapolis, Indiana, we are a leading global healthcare organization committed to the discovery and provision of life-altering medications. In order to make sure that our inventions reach the people who need them the most, our diverse team of professionals works relentlessly to improve the knowledge and management of diseases. Being a community and not just a place of employment, Lilly values volunteerism and philanthropy deeply.
Lilly’s Regulatory Business Integrator Position: Job Duties
You will be essential to the integration and management of regulatory software solutions at Lilly in order to ensure that they meet the business needs of the organization as a Regulatory Business Integrator. Your primary duties will consist of:
- Integration and Management of Technology
- directing the setup and integration of Veeva RIM and other regulatory software to satisfy operational requirements.
- Regulatory platform customization and optimization using Veeva Configuration and Integration.
- ensuring the smooth interface of enterprise apps and regulatory systems in order to automate processes and move data efficiently.
- working together on full-stack/veeva development projects with IT teams to improve regulatory procedures.
Regulatory Expertise
- provide comprehensive understanding of regulatory procedures such as publishing, authoring, submitting, and labeling.
- ensuring adherence to international regulations, such as those set forth by the FDA, EMA, and Health Canada.
- Staying informed about regulatory changes and industry developments is essential for maintaining compliance.
- Management of Stakeholders
- interacting with corporate stakeholders to comprehend their requirements about regulations and converting those demands into technical specifications.
- Controlling departmental expectations and coordinating IT solutions with corporate objectives.
- serving as a liaison to facilitate efficient communication and cooperation between IT and regulatory affairs.
Process Improvement & Compliance
- locating areas where regulatory operations can be improved through procedure, then putting technology-driven solutions in place.
- ensuring compliance with industry standards and best practices for all interconnected systems and solutions.
- directing programs for support and training to make ensuring users are competent in using regulatory systems.
Required Qualifications and Skills
In order to succeed in this position, applicants need to fulfill the following requirements:
- Education: A bachelor’s or master’s degree in regulatory affairs, life sciences, or a comparable discipline.
- expertise: More than five years of expertise in the biotechnology, pharmaceutical, or medical device industries in regulatory affairs.
- Technical expertise includes full-stack development experience, familiarity with Veeva RIM configurations and integrations, and knowledge of the software development lifecycle (SDLC).
- Regulatory Knowledge: Working knowledge of international regulatory frameworks, particularly as they relate to the FDA, EMA, and Health Canada.
- Project management: Demonstrated ability to manage multidisciplinary teams and projects in an international setting.
- Skills: Excellent interpersonal and communication skills, strong technical ability, and capacity for problem-solving.
How to Apply
Try applying for Lilly’s Regulatory Business Integrator position if you fit the requirements and want to have a big impact on the healthcare sector. The position is located in Bangalore, Karnataka, and applications must be submitted by September 10, 2024. This position presents a fantastic chance for individuals seeking to utilize their proficiency in technology integration and regulatory affairs to support a leading healthcare organization worldwide.
