Associate General Counsel, Global Regulatory Compliance - Remote

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Sr. Director, Associate General Counsel, Global Regulatory Compliance role reports directly to the VP, Chief Regulatory Counsel. This position will provide primary legal support for GxP quality, compliance, investigation, and enforcement activities, worldwide.

This role counsels clients on a wide range of regulatory compliance issues with a focus on current good manufacturing practices (GMP), good clinical practice (GCP), and good laboratory practice (GLP) and quality processes related to the research, development, manufacturing, and distribution of innovative, biosimilar, and generic pharmaceuticals around the world. The attorney will work collaboratively with cross-functional teams to develop, lead, and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans. The attorney will prepare and provide policies, trainings, and updates to management (and, occasionally, larger audiences) on developing legal matters, GxP best practices, and similar matters.

 
This role will collaborate with attorneys and other professionals inside and outside of the U.S., including outside counsel, who possess certain subject matter expertise to ensure all legal matters are assessed and handled capably.  

How you’ll spend your day

• Counsel clients on a wide range of regulatory compliance issues with a focus on current GxP practices and quality processes related to the research, development, manufacture, and distribution of innovative, biosimilar, and generic pharmaceuticals, worldwide.
• Work collaboratively with cross-functional teams to develop, lead, and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans.
• Participate in internal meetings to review quality metrics, participate in site or project governance committees, and facilitate internal audits.
• Partner with Compliance to provide legal support for internal investigations.
• Work cross-functionally with Quality, Regulatory, and other stakeholders to support process and system improvements, including development of global quality policies and training materials.
• Monitor and participate in the external policy environment and advise teams on policy and regulatory developments related to GxP activities.
• Manage a legal budget and ensure alignment with financial targets.
• Manage outside counsel who provide services in support of this role.
• Provide trainings to management and employees on emerging and/or hot legal topics.

Your experience and qualifications

• A Juris Doctor (JD) degree from a top tier law school is required.  
• A minimum of 8 years prior experience at law firm and/or in-house legal department is required.
• Legal experience working within manufacturing and/or R&D quality is required. 
• Admission to practice law in the bar of a relevant jurisdiction/ability to be house counsel.
• Demonstrated excellence in (i) understanding complex scenarios in order to identify and evaluate relevant issues and risks; (ii) proposing solutions that take into consideration the relevant business objectives; and (iii) communicating those issues, risks, and solutions clearly and concisely.
• Strong interpersonal skills and an ability to work collaboratively, with a solution-oriented approach, in global, cross-functional teams within legal, compliance, business, and other functional areas.
• Strong relationship-building skills, able to influence internal and external stakeholders. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility.
• Strong foundation of analytical skills, verbal, and written communication skills.
• Strong organizational skills and an ability to handle multiple responsibilities simultaneously and still meet quality and timeliness standards under pressure.
• Self-motivation, an ability to work proactively and independently, reliability, resp