Lilly Principal Consultant-RA-US Commercial in Greenfield, Indiana
Individual in this role provides leadership to the team responsible for regulatory review and approval promotional materials review and post-approval submissions associated with veterinary products (i.e. drugs, biologics, and pesticides) regulated by the US FDA Center for Veterinary Medicines (CVM), US Environmental Protection Agency (EPA), and USDA Center for Veterinary Biologics (CVB). In addition, this individual will work directly with the Elanco US Affiliate to strategically represent Elanco’s regulatory guidance in the development and approval of promotional materials; lead post-approval labeling changes, support post-approval CM&C submission; and provide regulatory advice to support the delivery of innovation to our customers for new launches or the launch of new indications.
Functions, Duties, Task:
Provides effective leadership and regulatory expertise to relevant Elanco business units (i.e. Companion Animal, Fool Animal, etc.), directing and coordinating all regulatory activities for the assigned products / portfolio
Responsible for ensuring professional planning, competent regulatory input, efficient maintenance of the registrations of existing marketing authorizations in accordance with business needs, directions and strategies.
Responsible for agency relations by maintaining close contacts to the relevant authorities.
Authority interactions may range from written communication to in-person meetings within the scope of responsibility.
Ensures regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submissions and strict participation in the global/local change control operations. Ensures regulatory compliance by timely submission of variations.
Influence and participate in industry-focused working groups.
Work effectively within and across internal teams and external collaborators to ensure compliance with all applicable regulations and internal policies and procedures.
Develop regulatory talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Ensures compliance to procedures and systems necessary to maintain proper regulatory records.
Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Thorough knowledge of regulatory regulations and guidelines that affect promotion and advertising
General knowledge of US regulations associated with veterinary drugs, biologics, and pesticides.
Strong oral and written communication skills and attention to detail in review and submission of promotional materials, variations, and label changes
Previous leadership / coaching experience, desirable but not essential
Ability to lead self & others in matrix driven environment – demonstrating the ability to build & maintain relationships across geographies
Ability to create a positive work environment, through influencing others & demonstrating listening & empathy
Models innovative behaviors and regulatory excellence attributes to create an innovative culture that aligns with company objectives.
Demonstrated aptitude for critical thinking & problem solving
Lilly 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.
Principal Consultant-RA-US Commercial
5 years of experience in veterinary regulatory position
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com . (Elanco only)
State / Province: