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Legal Regulatory Counsel for Established Products
Northbrook, IL Legal Regulatory Counsel for Established Products - Northbrook, IL Do you want to join a global pharmaceutical company and help develop innovative therapies for patients? Astellas Pharma Inc. is seeking a Legal Regulatory Counsel for Established Products in Northbrook, IL to provide legal regulatory advice and counsel for marketed products in Astellas' U.S. Established Products portfolio, with a primary focus on Cresemba, Xospata, Myrbetriq, AmBisome, Lexiscan, Prograf, and other strategic initiatives. This position also plays a supporting role in relation to marketed products and pipeline compounds in Astellas' Woman's Health portfolio, specifically Veozah. This role is responsible for balancing business opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment, minimizing legal and regulatory exposure and reputational damage. The Legal Regulatory Counsel will work closely with the Legal Regulatory Lead for Medical Specialties and Gene Therapy, and the Legal Regulatory Lead for US Market Access, to provide robust legal regulatory and healthcare compliance support to various Astellas functions and stakeholders. This includes reviewing and approving brand plans, promotional materials, and strategic planning tools, supporting product launches and life-cycle management, handling crisis management, and managing and resolving disputes related to marketing and promotional activities. Key Responsibilities: - Provide 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. - Review and approve brand plans, promotional materials, and strategic planning tools. - Support product launches and life-cycle management. - Handle crisis management and resolve disputes related to marketing and promotional activities. - Provide legal regulatory and healthcare compliance support in connection with U.S. market access activities and patient support program initiatives. - Serve as the Legal representative on applicable cross-functional committees. - Coordinate with Legal Regulatory lawyers with global responsibilities for Medical Specialties/US Established Brands. - Provide legal regulatory and healthcare compliance support to Medical Affairs teams responsible for Astellas Medical Specialties and Established Brands. - Stay abreast of and provide business clients with updates on changes in legal regulatory and enforcement-related developments affecting the pharmaceutical industry. - Perform special projects as assigned and demonstrate leadership ability. - Represent the Legal department on various cross-functional committees. - Supervise and direct outside counsel effectively, and efficiently manage legal expenses. - Coordinate closely with Ethics & Compliance colleagues. - Act as a member of legal-related industry or business community committees. - Support a legal culture of excellence within his/her team. - Lead 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: - Law Degree (Juris Doctor and licensed to practice law). - 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. - Experience in promotional material review, FDA-related matters, and PhRMA Code compliance. - Strong negotiation and communication skills. - Ability to manage large workload, multi-task, and focus on critical priorities. - Team player and able to build relationships on a global scale. - Strong organization and teamwork skills. - A strong commitment to integrity and professionalism. Working Environment: At Astellas, we recognize the importance of work/life balance and offer a hybrid working solution allowing time to connect with colleagues in 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. #LI-KT1 Category Legal Commercial, Regulatory and Privacy Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans |
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