Are you are Scientist or Engineer passionate about strategic regulatory guidance? Do you seek opportunity to work in new product development, lead regulatory submission process, and throughout product lifecycle? If so, a Regulatory Scientist role is calling for you. Global Regulatory Affairs leads the creation of regulatory strategy that expedites product development, improves the probability of success and mitigates risks. Scientists exercise considerable judgment in determining approach and then researches, prepares, and submits required regulatory documentation including those in response to inquiries during the regulatory review process. Daily utilization of regulations, guidelines, and regulatory precedence to expedite the development and delivery of safe and effective products to improve the patient experience is integral to the role. This position will support products in digital health, which may include software as a medical device (SaMD), mobile medical apps and/or embedded software (SiMD) as part of electromechanical devices. You will work in a collaborative team across multiple functions to integrate a successful regulatory strategy; developing and maintaining effective and mutually positive relationships across Lilly businesses, functions, partner companies, and with the FDA. Every single day you will....
Demonstrate knowledge from FDA meetings and regulatory trends to define the regulatory strategy and associated submission strategy.
Provide regulatory expertise to identify, prevent, and solve complex regulatory issues for product development.
Understand and communicate the benefits and risks of the product and ensures addressed in risk assessments.
Translate business unit needs / patient needs into product requirements and defined specifications.
Communicate and negotiate effectively with FDA and internal customers to ensure clear understanding and expectations of the strategy.
Provide high quality, timely, and critical regulatory advice to ensure well-informed decisions are made on new product development or lifecycle planning.
Your ability to influence the early lifecycle development, apply lessons learned, from other product development and competitor knowledge is crucial. In this role you should be able to....
Work effectively with internal and external organizations to assess regulations for potential new products and influence the development work to meet regulatory expectations.
Negotiate and influences regulators such as FDA (CDRH, OCP, DMEPA, etc).
Build, maintain, and leverage relationships with customers (particularly with FDA), team members, and partner companies as appropriate.
Internal Number: 45599
About Eli Lilly & Company
Company Overview 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 39,000 employees worldwide 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.