Assistant General Counsel US Regulatory Legal
Employment Type: Full-Time
Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.
* Reports directly to Deputy General Counsel, US.
* Responsible for counseling on North American 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; and health, safety and environment as well as inspectional and product safety/quality issues.
* Collaborates with cross-functional teams and counsels a variety of clients across Elanco businesses on regulatory legal issues, including product submissions, product field actions, product complaints, agency inspections, advertising and promotion, and manufacturing requirements.
* Resolves routine, moderately complex and complex legal regulatory matters with minimal supervision.
* Keeps abreast of changes in laws and regulations that affect the regulation of Elanco products, 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 acquisition activities.
* Applies innovative problem-solving skills and judgment to assist in managing corporate risk.
* Delivers work product within business constraints in a high-volume, fast-paced and demanding environment while balancing competing client requests.
* Comprehensive knowledge and understanding of 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 United States regulatory issues.
* Juris Doctor or equivalent legal degree
* Minimum six (6) years in practice and experience providing legal counsel on regulatory and quality matters relating to pharmaceutical products with a US based 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
* Qualified candidates must be legally authorized to be employed in the United States. Elanco Animal Health does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/Preferences :
* Prior government experience
* In addition to top-notch legal skills, must have excellent interpersonal, strategic thinking, communication and organizational skills.
* Strong business acumen and mindset towards collaboration.
* Previous in-house experience
Location: Preference for this role is at Elanco's corporate headquarters in Greenfield, IN (Indianapolis, IN) although will consider a remote worker with ability to travel to Greenfield as needed.
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