Director - Legal Regulatory

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Published date: October 17, 2020 10:44 am

Location: Northbrook, Illinois, United States

About the Job

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science.

The Director, Legal Regulatory is responsible for managing a breadth of complex legal and legal regulatory matters and providing practical, timely, strategic, and high quality legal regulatory advice and counsel to a broad spectrum of clients across the Astellas enterprise with primary responsibility for marketed products and pipeline compounds in Astellas' global Oncology portfolio and other strategic initiatives.

Essential Job Responsibilities:

The Director, Legal Regulatory will be responsible for the following, working closely with the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development and the Senior Director, Legal Regulatory (Oncology, Innovation, Patient Centricity, and Development):

* Providing robust legal regulatory and healthcare compliance support to Medical Affairs teams responsible for Astellas Oncology compounds, including advising on Medical Affairs strategies and tactics (including core medical plans).

* Reviewing internal and external presentations and materials (including news releases, policies, industry presentation and position statement materials), ensuring that all such presentations and materials meet applicable legal and regulatory requirements, coordinating with other colleagues in Legal, IP, and Ethics & Compliance as may be necessary.

* Staying abreast of and providing business clients with updates on changes in legal regulatory and enforcement-related developments affecting the pharmaceutical industry, coordinating with other leaders in the Legal function, as may be appropriate.

* Representing the Legal department on various cross-functional committees.

* Partnering with a global team of highly skilled and specialized lawyers and other professionals in multiple jurisdictions to assure timely, proactive, strategic and high-quality legal advice.

* Coordinating with Centers of Excellence in the General Counsel group as may be appropriate or needed.

* Retaining, supervising and directing outside counsel effectively, and efficiently managing legal expenses consistent with global budget for Legal Regulatory matters, coordinating closely with Legal & IP Operations.

* Coordinating closely with global Ethics & Compliance colleagues.

* Working with co-promotion partners to support brand teams, including coordinating and collaborating with partners' Legal representatives to provide comprehensive legal advice and guidance. Coordinating with members of the Astellas Legal department and Alliance Management to ensure compliance with co-promotion and collaboration agreements.

* Acting as a member of legal-related industry or business community committees such as JPMA, PhRMA, EFPIA, APBPI or other regional or local bodies.

* Leading other projects as may be requested by the Senior Director, Legal Regulatory (Oncology, Innovation, Patient Centricity, and Development); Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development; Legal Head of CRMD; or General Counsel.

* Overnight travel, including international travel, as needed.

Organizational Context:

* The Director, Legal Regulatory reports to the Senior Director, Legal Regulatory (Oncology, Innovation, Patient Centricity, and Development).

* Responsible for providing full range of legal support for all legal regulatory matters involving marketed products and pipeline compounds in Astellas' global Oncology portfolio and, as needed, other matters and strategic priorities for the organization.

Qualifications:

* Law Degree.

* Minimum of 7 years' experience working in a law firm or pharmaceutical legal department.

* Deep understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws.

* Strong work ethic and ability to manage large workload, multi-task, focus on critical priorities, and otherwise effectively meet client needs.

Ability to produce high-quality work under deadline pressures.

* Team player and able to build relationships, both internally and externally, on a global scale.

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