Assistant General Counsel – OUS Regulatory (EU)

Job Description:

This role is looking for a lawyer/senior associate with very good English, trained at a reputable law firm/company, if possible, with a bar exam and life science experience to join our General Law Department as Assistant General Counsel- OUS Regulatory.

Day-to-day responsibilities:

• Responsible for counseling on regulatory laws, regulations, and guidance documents from Europe, the Middle East, 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 company 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 the company, working with other company counsel and outside counsel as appropriate, with respect to global regulatory issues.

Basic Qualifications:

• 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 the ability to handle multiple projects in a fast-paced environment and exercise sound commercial and legal judgment.

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 toward collaboration.
• Previous in-house experience