Director, Global Regulatory Affairs, Neuroscience - ...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy NoticeandTerms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. TheDirector Global Regulatory Affairs, Neuroscienceis responsible fordeveloping innovative global regulatory strategies andprovidingstrategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.This isaccomplishedthrough leadership of product-specific Global Regulatory Teams (GRTs) andrepresentingthe regulatory function on cross-functional Global Program Teams. Defines,develops, and leads global strategies tomaximizeglobalregulatorysuccesstowardsachievement ofprogramobjectivesforcomplexand/or multiple projects.Keepsabreastof newdevelopmentsinregulatoryscience andmaintainsoversighton theevolvingregulatorylandscapeandadvancinginnovations.Understandsandinterpretsscientificdataasitrelatestoregulatoryrequirementsand strategyforassignedprojects andprovidesknowledge and expertise to guide team inestablishedandbuilding appropriateregulatorystrategy.Participatesincross- functionalinitiativeswithinGlobalRegulatoryAffairsand Takeda R&D.How you will contribute: The Director willbe responsible forincreasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groupsandrepresentsGRT at project team meetings.Defines strategies and provides tactical guidance to teamsand collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.Ensures project team colleagues, line management, and key stakeholders are apprised of developments that mayimpactregulatory success,exercisingsound judgement and communicating in a professional andtimelymanner.Proactivelyanticipatesrisks and responsible for developing solutions toidentifiedrisks and discussing with team and management; understands probabilities of technical success for the solutions.Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will leadhighly complexsubmission types such as original NDA/BLAs.Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.Accountable for working with regulatory regional leads, otherfunctionsand vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and tomaintaincompliance for products.Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.Participates with influence in departmental and cross-functionaltask-forcesand initiatives.Lead regulatory reviewer in due diligence for licensing opportunities.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 to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.Responsible fordemonstratingTakeda leadership behaviorsMinimumRequirements/Qualifications:BSc Degree, preferred. BA accepted.10+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience orcombinationof 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,ROWand post-marketing a plus.Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge andexpertiseto guide team inestablishedand buildingappropriate regulatorystrategy.Strong oral and written communications, managing and adhering to timelines, negotiation skills,integrityand adaptability.Demonstrates acceptable skills with increasing independencein the area ofregulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactivelyidentifiesregulatory issues; offers creative solutions and strategies, including risk mitigation strategies.Must work well with others and within global teams.Acceptable and independent skillsin the area ofregu

Created: 2026-04-06