Director, Legal Regulatory
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 Director, Legal Regulatory in Northbrook, IL.
Purpose & Scope:
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.
This is a strategic position and is accountable for balancing business 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 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 global, divisional, and local functions and stakeholders, including Oncology Sales & Marketing, Commercial Strategy & Capabilities, Health Systems, Regulatory Affairs, Medical Affairs, Development, Global Market Access, Corporate Communications, Policy & Government Affairs, and Ethics & Compliance, ensuring best-in-class legal advice, consistent with best practices in the pharmaceutical industry, the company’s global legal strategy and local/regional legal practices and requirements.
- Providing robust legal regulatory and healthcare compliance support to Oncology brand teams, including reviewing and approving brand plans, promotional materials, and strategic planning tools; supporting product launches and life-cycle management; handling crisis management; managing and resolving marketing and promotional disputes; advising on patient support programs; advising on advisory boards and other non-promotional activities; and representing the Legal Department in relevant meetings and on committees.
- 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.
- Working with the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development and the Legal Regulatory Lead for Medical Specialties, Market Access, PV & Quality to ensure a globally consistent approach to legal regulatory support taking into account unique aspects required for a particular client group as well as specific jurisdictional legal requirements.
- Collaborating with Affiliate lawyers in the U.S., Established Markets, International, Japan, and Greater China Divisions (collectively referred to as the “Divisions”). “Affiliate lawyer” shall mean a lawyer based in an Astellas office outside of the office locations in Tokyo, London and Chicago who reports to/through one of the Legal Commercial Leads for the Divisions. Specifically with respect to the Affiliate lawyers in the Divisions, 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 Director, Legal Regulatory will work closely and coordinate with the respective Legal Commercial Lead for the relevant Divisions and the relevant Affiliate lawyers to determine who shall lead a particular matter and otherwise assure 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) for the Divisions and the Director, Legal Regulatory will vary depending on its materiality and complexity as determined by the Senior Director, Legal Regulatory (Oncology, Innovation, Patient Centricity, and Development) and the Legal Regulatory Lead for Oncology, Innovation, Patient Centricity, and Development in consultation and coordination with the Legal Commercial Lead for the Divisions 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.
- 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.
- Supporting a legal culture of excellence within his/her 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 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.
- 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. Works closely with members of all functions across the Astellas enterprise, including Sales and Marketing, Commercial Strategy & Capabilities, Health Systems, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Global Market Access, Medical Affairs, Development, Corporate Communications, Policy & Government Affairs, and Ethics & Compliance.
- 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 Medical Specialties, Market Access, PV & Quality) 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.
- 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 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.
- 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 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.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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Job posted: 2020-10-15