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Astellas Pharma Senior Director, Legal Regulatory in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Senior Director, Legal Regulatory in Northbrook, IL.

Purpose & Scope:

The Senior Director, Legal Regulatory is responsible for managing a breadth of complex legal and 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 Astellas' US Health Systems business plans and strategic initiatives.

This is a highly strategic position and is accountable for balancing commercial opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment to minimize legal and regulatory exposure and reputational damage in an area of high potential liability. This position is also accountable for proactively identifying and mitigating risks to the Company's ability to achieve its corporate objectives under the Corporate Strategic Plan.

Essential Job Responsibilities:

The Senior Director, Legal Regulatory will have the following responsibilities:

  • Independently reviewing, analyzing and keeping current on federal, state, and international legal developments and enforcement actions affecting the pharmaceutical industry, and informs colleagues within the Legal and Compliance functions and advises clients accordingly regarding the same, including without limitation FDCA, outside government investigations involving the False Claims Act and Anti-Kickback Statute, OIG Guidance, PhRMA Marketing Code and Fraud and Abuse Issues and Anti-Bribery and Anti-Corruption. Also, recommending to the Legal Regulatory Lead for Medical Specialties, Market Access, PV & Quality and Senior management of US Health Systems potential improvements in process and areas for training both within Legal, and for any Astellas business units.
  • Serving as a strategic legal partner to business leaders and their teams by leading, managing and overseeing the full range of legal regulatory support, advice and counseling, including providing timely, proactive, strategic, best-in-class legal advice and support, taking into account the global objectives of the organization, the Corporate Strategic Plan, and the unique and varying legal regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk. In this regard, the Senior Director, Legal Regulatory will also align, coordinate and work closely with other key stakeholders and other members of the Legal and IP Legal teams as may be needed or appropriate.
  • Leading, managing, and overseeing the full range of legal regulatory and healthcare compliance support for development, launch, commercialization, and post-marketing activities throughout the lifecycle of Astellas' compounds and products. Such support includes providing legal advice, including the legal interpretation of laws, rules, regulations and guidance documents relating to the development and commercialization of pharmaceutical products and reviewing promotional materials for those products.
  • Working with the Legal Regulatory Lead for Medical Specialties, Market Access, PV & Quality and the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development to ensure a globally consistent approach to Legal Regulatory support taking into account unique aspects required for a client group as well as specific jurisdictional legal requirements.
  • Overseeing and providing senior management and business clients updates on changes in legal regulatory developments affecting the pharmaceutical industry, coordinating with other leaders in the Legal function, as may be appropriate.
  • Collaborating with Affiliate lawyers in the U.S. "Affiliate lawyer" shall mean a lawyer based who reports to/through one of the Legal Commercial Leads. Specifically, with respect to the Affiliate lawyers, there is a recognition and understanding that these lawyers provide general legal support to their respective General Managers and Affiliate leadership teams which often goes beyond commercial and back office support, including support for various local matters covered by the Legal Regulatory Leads and their teams (collectively, "Local Matters"). With respect to Local Matters, the Senior Director, Legal Regulatory will work closely and coordinate with the respective Legal Commercial Lead and the relevant Affiliate lawyers to determine who shall lead a particular matter and otherwise ensure that such Local Matters are handled consistently with global policies and practices taking into account unique local or regional legal requirements that may exist (or the General Counsel shall so determine in the event there is no consensus). The level of involvement and extent of coordination and collaboration on a Local Matter between the applicable Affiliate lawyer(s)/Legal Commercial Lead(s) and the Senior Director, Legal Regulatory will vary depending on its materiality and complexity as determined by the Legal Regulatory Lead for Medical Specialties, Market Access, PV & Quality in consultation and coordination with the Legal Commercial Lead and Legal Head of CRMD. Notwithstanding the foregoing, if a Local Matter is an investigation (internal or third party), any such investigation shall be led by the global ILE team. The ILE team shall closely collaborate with the Legal Head of CRMD and he/she will communicate as appropriate to the Legal Regulatory Leads.
  • Representing the Legal department on various cross-functional committees.
  • Leading, managing and developing or 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.
  • Assisting the Legal Regulatory Lead for Medical Specialties, Market Access, PV & Quality Development and the Legal Head of CRMD in reporting to the General Counsel, top management and the Board of Directors of Astellas Pharma Inc.
  • 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.
  • Acting as a member of legal-related industry or business community committees in US such as PhRMA.
  • Leading a legal culture of excellence within their team which includes driving and fostering: (1) an agile, adaptive culture; (2) a value-based organization based on Legal's Mission and objectives; (3) a culture of innovation, transparency and trust; (4) proactive identification/mitigation of risk in a balanced approach; (5) empowerment and engagement of the team members; (6) a collaborative culture with close coordination with other members of Legal and IP as appropriate to leverage synergies and efficiencies; (7) a culture of compliance and good corporate governance; and (8) a continuous expectation of high performance, where "ok" is not good enough.
  • Leading other projects as may be requested by the Legal Regulatory Lead for Medical Specialties, Market Access, PV & Quality, Legal Head of CRMD, or General Counsel.
  • Overnight travel, including international travel, as needed.

Quantitative Dimensions:

Organizational Context:

  • The Senior Director, Legal Regulatory reports to the Legal Regulatory Lead Medical Specialties, Market Access, PV & Quality and is a member of the leadership team of Medical Specialties, Market Access, PV & Quality.
  • Responsible for providing full range of legal support for all legal regulatory matters involving US Health Systems and as needed, other matters and strategic priorities for the organization. Works closely with leaders in all functions across the US Astellas enterprise, including Sales and Marketing, Health Systems, Regulatory Affairs, Medical Affairs, Development, Government Affairs, and Ethics & Compliance plus Global Market Access.
  • Works closely, collaborates, and coordinates with other teams reporting into the Legal Head of Commercial, Regulatory and M&D ("CRMD") (including the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development) as well as the Legal Heads of Innovation, Governance, Technology and Data ("IGDT"); Corporate Strategic Transactions ("CST"); Investigations, Litigation and Employment ("ILE"); IP Legal and Legal & IP Operations.

Qualifications:

Required

  • Law Degree.
  • At least 10-12 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 knowledge of global regulatory environment that affects decision-making across Astellas' global business. In-depth understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory and commercial elements. Experience in promotional material review, FDA-related matters, and PhRMA Code compliance.
  • Ability to effectively lead a legal team in a complex multi-jurisdictional environment for a multinational pharmaceutical company. Strong experience and knowledge of best practices relating to legal matters in the pharmaceutical industry in various jurisdictions (including the USA).
  • Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice in a time-sensitive dynamic and fast-paced complex global environment.
  • Strong management and leadership skills, including the ability to effectively motivate and manage a broad-based team.
  • Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Inspires trust and confidence through effective communication and interpersonal skills.
  • 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.
  • Strong organization and teamwork skills. Detail-oriented, self-motivated and able to motivate others.
  • A strong commitment to integrity and professionalism and demonstrated passion for excellence.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Legal

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