Fall 2026 Co-Op - Regulatory Affairs

Why Boehringer Ingelheim?Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.DescriptionBoehringer Ingelheim is currently seeking a talented and innovative Fall Co-op to join our Regulatory Affairs department located at our Athens, GA office.Boehringer Ingelheim Animal Health is currently seeking a talented and innovative co-op to join our Regulatory Affairs department located at our Duluth/Athens facility. In this role you will work with our safety and efficacy or CMC team to support regulatory submissions to US FDA CVM and USDA CVB and and improve compliance tracking of submission applications and improve linkage between regulatory guidelines and internal Boehringer documents .As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities Review and update the Internal Reference List with relevant ICH and US regulations, and FDA Guidances, Q&As, preambles and regulatory history Lead improvement projects related to: NDA and BLA submission templates, submission project managment tools, work instructions and tools used for CMC submissions, and post-approval change processes Perform conformance review for compliance to CTD specifications, standards and best practice for NDAs and BLAs Support NDA and BLA compliance submissions RequirementsMust be a current undergraduate, graduate or advanced degree student in good academic standing. Student must be enrolled at an accredited college or university for the duration of the co-opOverall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferredMajor or minor in related field of co-opUndergraduate students must have completed at least 12 credit hours at current college or universityGraduate and advanced degree students must have completed at least 9 credit hours at current college or universityFor students on a work visa, student must have pre-approved visa through the current college or university and eligibility to work 40 hours/week for six (6) months or moreEligibility Requirements:Must be legally authorized to work in the United States without restrictionMust be willing to take a drug test and post-offer physical (if required)Must be 18 years of age or olderAdditional Desired Skills, Experience And Abilities Excellent communication (verbal and written) skills Excellent skills in planning, organizing, and problem-solving Computer and information technology literacy Ability to work well under pressure, work in a team environment, flexibility to adapt in a changing environment. Detail oriented, well organized. Our CompanyWhy Boehringer Ingelheim?With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.Want to learn more? Visit https://www.boehringer-ingelheim.com