Assistant General Counsel OUS Regulatory, Litigation and HR
EMEA (any Elanco office within the region)
Europe; Middle East; Africa
Founded in 1954, Elanco is a global research-based company that develops and delivers products and services to enhance animal health and production. Our products, services and global partnerships support our vision of enough food and companionship enriching life. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,500 employees in more than 70 countries.
Reports directly to Associate General Counsel, Head of Regulatory and Litigation.
Responsible for counseling on OUS 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; 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, patient 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 EU regulatory law 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.
Act as day-to-day OUS employment attorney for Elanco.
Advise management, Human Resources and other Elanco lawyers with respect to OUS employment law issues, including business restructuring, employment policy development and application, worker classification, workforce management, discrimination and harassment claims, wage-and-hour and workplace safety.
Oversee and provide counsel on internal investigations of OUS employment-related and other types of complaints, ensuring that claims are addressed promptly, thoroughly and appropriately.
Draft settlement and separation agreements; draft mediation briefs and position statements and responses.
Create and deliver management and employee training programs.
Provide strategic advice and counsel regarding OUS labor law and union contract obligations.
Represent Elanco, working with other Elanco and outside counsel as appropriate, with respect to OUS regulatory issues, mediation and litigation of employment claims and the employment-related aspects of acquisitions and dispositions of businesses.
Act on behalf of company, with support as necessary, in grievances, arbitrations and proceedings before OUS labor boards, including but not limited to European Works Councils.
Advise client in connection with response to OUS union organizing activity.
Juris Doctor or equivalent legal degree
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; prior government experience is also beneficial
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
High level of English fluency
* Strong business acumen and mindset towards collaboration. * Previous in-house experience on a global basis preferred.
Location: this position is located in Europe, Middle East or Africa (EMEA). Reports to: Assistant GC-Regulatory and Litigation Travel requirements: up to 10%