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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
This role can be based in the West Chester, PA or the Parsippany, NJ locations.  Hybrid schedule – 3 days on-site and 2 days remote. 

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.