At least four (4) years in practice and experience in providing legal counsel on regulatory and quality matters with a major corporation or law firm.
Must have demonstrated ability to perform successfully in cross-functional teams, with the ability to lead and mentor
Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment
Responsible for counseling on regulatory laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of animal health products; product cybersecurity; lifecycle management; health, safety and environment; and privacy legal issues; as well as inspectional and product safety/quality issues.
Collaborates with cross-functional teams and counsels a variety of clients across Elanco businesses on moderately complex legal regulatory issues, including product submissions, product field actions, product complaints, agency inspections, advertising and promotion, and manufacturing requirements.
Resolves routine and moderately complex to complex legal regulatory matters with minimal supervision.
Keeps abreast of changes in laws and regulations that affect the regulation of Elanco products, and identifies opportunities to influence content and engages in external influencing efforts.
Interacts and provides legal and strategic guidance to senior management and functional organizational leadership.
Conducts regulatory due diligence in connection with any potential animal health product acquisition activities.
In addition to top-notch legal skills, must have excellent interpersonal, strategic thinking, communication and organizational skills.
Apply innovative problem solving skills and judgment to assist in managing corporate risk.
Ability to deliver work product within business constraints in a high-volume, fast-paced and demanding environment while balancing competing client requests.
Comprehensive knowledge and understanding of US regulatory laws, including laws implemented by USDA, FDA, EPA and relevant state regulatory authorities, so as to be able to evaluate situations and act decisively by understanding the short-term, intermediate, and long term business and legal implications of decisions being made or under consideration.
Experience leading or ability to lead large scale, complex legal projects and to propose practical options for meeting client business goals within applicable legal and regulatory requirements.
Represent Elanco, working with other Elanco and outside counsel as appropriate, with respect to regulatory issues.
Additional Skills/Preferences :
Prior government experience
Strong business acumen and mindset towards collaboration.
Previous in-house experience on a global basis.
Additional Information :
Reports directly to Deputy General Counsel, Head of HR, Regulatory and Litigation.
This position is located in Greenfield, IN or Washington, DC
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
Employer will assist with relocation costs.
Internal Number: R0003839
About Elanco Animal Health
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954. Our worldwide headquarters and research facilities
are in Greenfield, Indiana.
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