March 20, 2023 7:48 pm CDT

Senior Director, Global Regulatory Affairs, GI – Hybrid

  • Freelance
  • Anywhere

Takeda Pharmaceutical

nn 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’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. nn nn nn nn n Job Description n nn nnAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Senior Director, Global Regulatory Affairs, GI – Hybrid.nn nn nn nnHere, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs GI team, you will be empowered to provide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval, and a typical day will include: nn nn nn nn OBJECTIVES/PURPOSE nn nProvides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval.n nDevelops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization.n nServes as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable.n nn nn nn ACCOUNTABILITIES nn nThe Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success.n nPartner with direct reports to ensure global market access consideration are being addressed  and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.n nEnsures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions.n nEffectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.n nAccountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.n nParticipates with influence in or leads departmental and cross-functional task-forces and initiatives.  Influence non-direct reports within Therapeutic Area, across GRA and across R&D.n nProvide regulatory strategy support to diligence for licensing opportunities as appropriaten nMonitor 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.n nResponsible for demonstrating Takeda leadership behaviors.n nn nn nn DIMENSIONS AND ASPECTS nn nn Technical/Functional (Line) Expertise nn nComprehensive understanding of the pharmaceutical industry and global regulatory strategy experience.n nn nn nn Leadership nn nDemonstrated ability to work across functions, regions and culturesn nFunctional level leadership with the ability to inspire, motivate and drive resultsn nExcellent communicator, able to persuasively convey both ideas and data, verbally and in writingn nProven skills as an effective team player who can engender credibility and confidence within and outside the companyn nAbility to distil complex issues and ideas down to simple comprehensible termsn nDemonstrates leadership presence and confidencen nEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizationn nBuilds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.n nInvests time in helping others to enhance their skills and perform at a higher leveln nn nn nn Decision-making and Autonomy nn nDecision making responsibilities:n nProvide input to highly complex decisions that impact the functional arean nAccountable for decision making for designated functionn nAbility to seek diverse input from multiple constituents and stakeholders to drive innovative solutionsn nAbility to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution n nAccountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-solving)n nn nn nn Interaction nn nEffectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplacen nCultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.n nEffectively represents function in negotiations with the ability to resolve conflict in a constructive mannern nAbility to build strong relationships and collaborate effectively with other interfacing Takeda functionsn nn nn nn Innovation nn nForward thinking with the ability to recommend, influence and implement organizational change and continuous innovationn nComfortable challenging the status quo and bringing forward innovative solutionsn nAbility to take risks implementing innovative solutions, accelerating time to marketn nIdentifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.n nRole models respect and inclusion, creating a culture that fosters innovationn nn nn nn Complexity nn nAbility to work in a global ecosystem (internal and external) with a high degree of complexityn nDeep expertise requiredn nAbility to see and understand broader, enterprise level perspective n nn nn nn EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  nn nAdvanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) preferred.  BA accepted.n n12+ years of pharmaceutical industry experience.  This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. n nPreferred experience in reviewing, authoring, or managing components of regulatory submissions. n nSolid working knowledge of drug development process and regulatory requirements.  Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. n nUnderstand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.n nUnderstands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.n nStrong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.n nDemonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovativen nSolutions and strategies, including risk mitigation strategies.n nMust work well with others and within global teams. n nAble to bring working teams together for common objectives.n nAcceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.n nn nn nn WHAT TAKEDA CAN OFFER YOU: nn n401(k) with company match and Annual Retirement Contribution Plann nTuition reimbursementn nCompany match of charitable contributionsn nHealth & Wellness programs including onsite flu shots and health screenings




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