Regulatory Affairs Promotional Review Consultant

Regulatory Affairs Promotional Review Consultant Represent the Regulatory US Affiliate to ensure regulatory compliance and timely submissions for post‑approval regulatory activities related to assigned pharmaceutical (FDA‑CVM) products and/or areas of responsibility. Additionally, demonstrate leadership by providing innovative solutions, promoting a positive work environment, and effectively communicating to ensure delivery and maintenance of Elanco’s food animal and pet health pharmaceutical portfolio. Responsibilities Maintain a broad overview of all post‑approval activities related to assigned products and/or areas of responsibility. Provide regulatory guidance in the development and approval of promotional materials for the Elanco US Affiliate to support the food animal and pet health marketed pharmaceutical products and new launches. Support post‑approval label changes, CMC updates, periodic reports and other post‑approval submissions to FDA‑CVM, including compilation, submission and archival. Lead project teams to comply with non‑standard post‑approval requests and authority mandates. Collaborate with other functional areas (Global CMC, Marketing, Legal, Technical, Labeling, Supply Chain, Quality, etc.) and external partners to promote regulatory awareness of and compliance with applicable regulations and internal policies and procedures. Represent Elanco in direct communications with FDA‑CVM, including written correspondence and leading meetings as required by the project. Maintain positive business collaboration and influence with Elanco Reg Affiliates, Reg Innovation, FDA‑CVM and industry groups. Perform other related duties and assignments as required by the business and directed by management. Minimum Qualifications Master’s degree or equivalent with at least 5 years of relevant work experience within the sciences or related areas. Solid understanding of US FDA‑CVM regulatory post‑approval requirements. Strong ability to interpret and leverage scientific data for promotional purposes while maintaining compliance with regulations. Preferred Qualifications Experience with promotional material/technical material review in the FDA/EPA space. Self‑management skills in an environment with diverse needs and demanding, and often urgent, timelines. Demonstrated ability to collaborate across organizations and develop compliant solutions that meet the needs of all parties. Strong oral and written communication skills and attention to detail. Additional Information Domestic and international travel, up to 5%. Location: Indianapolis, IN. Compensation Anticipated base salary range: $118,800.00 – $150,000.00, depending partly on qualifications. Eligible for company bonus and other incentive programs. Full‑time employees also eligible for a company matching 401(k) and other benefits. Benefits and Perks Comprehensive benefit program includes medical, dental, vision, prescription drug, flexible spending accounts, life insurance, and death benefits. Vacation, paid time off, and additional leave of absence benefits. Employee assistance program, fitness benefits, and employee clubs. Annual bonus offering up to 6% 401(k) matching. Flexible work arrangements and two weeklong shutdowns (mid‑summer and year‑end) in the US. 8‑week parental leave and relocation packages. EEO Statement Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #J-18808-Ljbffr Elanco Tiergesundheit AG