Associate Director, Global Regulatory Affairs Marketed Products

Overview As an Associate Director, Global Regulatory Affairs Marketed Products you will: lead and contribute global strategies to maximize regulatory success for complex and multiple projects; provide strategic and tactical advice to ensure timely development and maintenance of programs while ensuring compliance with applicable regulatory requirements; serve as a leader within the department and contribute to cross‑functional Takeda initiatives; and act as the global regulatory lead responsible for designing and executing global regulatory strategies in collaboration with regional counterparts. Responsibilities Lead the Global Regulatory Team (GRT) and sub‑working groups such as the Label Working Group, representing the GRT at project team meetings as global and/or regional regulatory lead. Define strategies and provide tactical guidance to teams, collaborating cross‑functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating professionally and timely. Proactively anticipate risks and develop scenario plans with solutions, discussing them with team and management; understand probabilities of technical success for solutions. Accountable for execution of global regulatory strategy, including provision of global regulatory submissions to local Takeda affiliates in compliance with local regulations, working with regional leads, other functions, and vendors. Accountable for US FDA submissions and approvals of projects; lead all submission types and serve as the primary FDA contact. Lead and manage FDA meetings, demonstrating Takeda leadership behaviours, managing junior staff as needed, and overseeing vendor responsibility for regulatory activities and submissions. Participate in departmental and cross‑functional task–forces and initiatives, and partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product‑specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments, strengthening product development plans and adopting regulatory strategies in a timely manner. Support the lead regulatory reviewer in due diligence for licensing opportunities. Qualifications BSc Degree (preferred); BA accepted. 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post‑marketing a plus. Ability to understand and interpret complex scientific issues across multiple projects and translate them into regulatory requirements and strategy. Strong oral and written communication skills, with the ability to manage and adhere to timelines, negotiate, and act with integrity and adaptability. Proven independent regulatory strategy skills, including understanding core regulatory concepts and their global implications. Ability to proactively identify regulatory issues and propose creative, practical solutions and strategies, including risk mitigation. Equal Employment Opportunity Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr Takeda Pharmaceuticals International GmbH