As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Position Description
Elanco is currently looking for a lawyer / senior associate with very good English, trained at a reputable law firm / company, if possible, with bar exam and life science experience to join our General Law Department as Assistant General Counsel- OUS Regulatory.
Functions, Duties, Tasks
* Responsible for counseling on regulatory laws, regulations, and guidance documents from Europe, the Middle East, and Africa and Asia-Pacific regions with respect to complex regulatory issues relating to the development, approval, manufacturing, marketing, distribution, importation, and lifecycle management of animal health products; inspectional and product safety/quality issues; and trade/customs compliance.
* 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, manufacturing requirements, and trade/customs compliance.
* Resolves routine, moderately complex and complex legal regulatory matters with minimal supervision.
* Interacts and provides legal and strategic guidance to senior management and functional organizational leadership.
* Interacts with regulators and other external stakeholders to resolve regulatory matters.
* 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 health authorities from Europe, the Middle East, and Africa and Asia-Pacific regions, so as to be able to evaluate situations and act decisively by understanding 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 global regulatory issues.
Minimum Qualification (education, experience and/or training, required certifications)
* Juris Doctor or equivalent legal degree
* Minimum five (5) years in practice and experience providing legal counsel on regulatory and quality matters relating to pharmaceutical products
* Must have demonstrated ability to perform successfully in cross-functional teams, with the ability to lead
* Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment
Additional 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
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