Legal Regulatory Counsel for Established Products

Legal Regulatory Counsel for Established Products

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.

Purpose:

The Legal Regulatory Counsel for Established Brands 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 in Astellas' U.S. Established Products portfolio of focusing strongly on Cresemba, Xospata and occasionally on Myrbetriq, AmBisome, Lexiscan and Prograf and other strategic initiatives.

The Legal Regulatory Counsel role for Established Brands will also play a supporting role in relation to marketed products and pipeline compounds in Astellas' Woman's Health portfolio, specifically Veozah. The role will also encompass playing a supporting role advising on U.S. market access activities across multiple commercial channels (e.g., IHNs, payers, GPOs, specialty pharmacies) and U.S. patient support program initiatives.

This role 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:

This position will be responsible for the following, working closely with the Legal Regulatory Lead for Medical Specialties and Gene Therapy and the Legal Regulatory Lead for Medical Specialties and the Legal Regulatory Lead for US Market Access.

• Providing robust legal regulatory and healthcare compliance support to Astellas functions and stakeholders, primarily for the US Established Brands and secondary legal support for the Veozah brand team and some including Sales & Marketing, Market Access and Commercial Capabilities, Regulatory Affairs, Medical Affairs, Development, Commercial Strategies, Corporate Communications, 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 U.S. Established Brands and Veozah 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 disputes related to marketing and promotional activities; advising on advisory boards and other non-promotional activities; and representing the Legal Department in relevant meetings and on committees .This will include providing primary legal support to the US Established Brands Commercial team covering several products and secondary legal support to the Veozah team including participating on the relevant Materials Approval Process (MAP ) teams.
• Providing robust legal regulatory and healthcare compliance support in connection with U.S. market access activities across multiple commercial channels (e.g., IHNs, payers, GPOs, specialty pharmacies) and U.S. patient support program initiatives covering a variety of products
• Serve as the Legal representative on applicable cross-functional committees tasked with reviewing data purchase requests and other proposed fee-for-service arrangements.
• Coordinating with Legal Regulatory lawyers with global responsibilities for Medical Specialties / US Established Brands to assure matters are handled consistently across the brands and with global policies and practices considering unique local or regional legal requirements that may exist.
• Providing robust legal regulatory and healthcare compliance support to Medical Affairs teams responsible for Astellas Medical Specialties and Established Brands, 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 Medical Specialties and Gene Therapy and the Legal Regulatory Lead for Legal Regulatory Lead for Oncology and Ophthalmology 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.
• Performing special projects as assigned and demonstrating leadership ability when helping the company to analyze innovative approaches.
• Representing the Legal department on various cross-functional committees.
• Supervising and directing outside counsel effectively, and efficiently managing legal expenses consistent with the global budget for Legal Regulatory matters, coordinating closely with the Legal Strategic Planning and Execution Team
• Coordinating closely with Ethics & Compliance colleagues.
• Acting as a member of legal-related industry or business community committees such as PhRMA, 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; and (7) a culture of compliance and good corporate governance;
• Leading other projects as may be requested by the Legal Regulatory Lead for Medical Specialties and Gene Therapy; Legal Head of Commercial, Regulatory, and Privacy; or General Counsel.
• Overnight travel, including international travel, as needed.

Qualifications Required:

• Law Degree (Juris Doctor and licensed to practice law).
• Minimum of 5-7 years' related experience working in a law firm or corporate legal department.
• Prior legal experience handling regulatory counseling matters for a company in the pharmaceutical or medical device industry.
• Deep understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes for prescription drugs and fraud and abuse principles
• 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.
• 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.

Working Environment:

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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Category Legal Commercial, Regulatory and Privacy

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans