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Director, Regulatory Publishing and Submission Management

Company: Takeda Pharmaceutical
Location: Le Roy
Posted on: November 24, 2022

Job Description:

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as -a Director, Regulatory Publishing and Submission Management? to be based -in Zurich. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVES: This key position is part of Global Regulatory Operation (GRO) and reports to the Global Head of Publishing. - The Director, Publishing and Submission Management will support both strategic and operational activities:

  • Develops and applies a comprehensive understanding of global RA regulations and guidelines on differenct submission types/formats (NeeS, eCTD, Paper, ACTD, eCopy, IMPD, PIP, DMF, ASMF etc. ) to projects to enhance probability of regulatory success and regulatory compliance.
  • Partner with project management and functional areas to develop strategic plans for health authority submissions and interactions.
  • Monitors global health authority regulations, guidelines, and specifications inmarkets such as US, EU, EMEA, Canada, AU, CH, GCC, EAEU and APAC for regulatory submissions to ensure compliance. Offer expertise and guidance to Regulatory Strategy and key stakeholders to support regulatory submissions with global health authorities
  • Liaises with other functional managers to ensure consistency of departmental approach within the company.
  • Leverage relationships with our suppliers to support business needs, support execution on business plans for the performance of the group. He/she will apply business and management expertise to drive operational performance across the Regulatory organization and be accountable for resolution of less complex operational issues and will work with the Head of Gloabl Regulatory Publishing to resolve highly complex or unusual operational issues.ACCOUNTABILITIES:The Director, Publishing and Submission Management will demonstrate Takeda leadership behaviors to accomplish the following responsibilities that include but are not limited to:You are a great fit for this opportunity if you are engaged and energized by:
    • Sets functional goals which contribute to department's vision and long-range planning.
    • Develops effective relationships with external publishing vendors/ contractors and software providers as appropriate to facilitate effective processing of the regulatory submission workload.
    • Significantly contributes to establishing budgets, schedules, work plans and KPIs.
    • Makes decisions on administrative and operational matters and ensures the publishing team effectively achieves its objectives.
    • Sets operational strategies for improving regulatory affairs systems/processes for the efficient publishing and archiving of regulatory submissions.
    • Promotes partnerships with project/program teams to ensure the company meets all key submission milestones.
    • Represents the company at relevant industry forums and/or software user groups.
    • When necessary and appropriate, steps in for or lends assistance to direct and indirect reports to help drive results and achieve objectives.
    • In-depth knowledge of company people management policies and procedures including hiring, performance management, corrective action, and compensation administration
    • Advanced leadership skills including change management, people development, strategic thinking and influencing
    • Ability to translate high level corporate strategy into long-range project plans to gain competitive advantage
    • Advanced knowledge of regulatory publishing and electronic document management systems
    • Excellent written and oral communication skills
    • Skill in setting data quality standards and KPIs and measuring/reporting/improving compliance
    • Ability to manage operational responsibilities across disciplines and multiple regions/countriesCORE ELEMENTS RELATED TO THIS ROLE :Leadership
      • Demonstrated ability to work across functions, regions and cultures
      • Functional level leadership with the ability to inspire, motivate and drive results
      • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
      • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
      • Ability to distil complex issues and ideas down to simple comprehensible terms
      • Demonstrates leadership presence and confidence
      • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
      • Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
      • Invests time in helping others to enhance their skills and perform at a higher levelDecision-making and Autonomy
        • Decision making responsibilities:
        • Provide input to highly complex decisions that impact the functional area
        • Accountable for decision making for designated function
        • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
        • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
        • Accountable for providing input to and implementing vision and strategy for designated scopeInteraction
          • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
          • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
          • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
          • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functionsInnovation
            • Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
            • Comfortable challenging the status quo and bringing forward innovative solutions
            • Ability to take risks implementing innovative solutions, accelerating time to market
            • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
            • Role models respect and inclusion, creating a culture that fosters innovation
            • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
            • Deep expertise required
            • Ability to see and understand broader, enterprise level perspectiveEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
              • 12 + years of experience in pharmaceutical/biotech industry, with 10+ years of hands-on global regulatory submissions management and publishing experience.
              • Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
              • At least 8 years managing individual contributors in addition to the ability to lead by influence and work effectively in matrix organizational structures
              • Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
              • Experience with supporting and leading successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projects
              • Understanding of relationship management with demonstrated experience in partnering in large scale situations
              • Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.
              • Expert at motivating individuals and teams to manage the change aspects of implementing a new, outsourced model.
              • Must have proven track record to be able to think critically, strategically, independently and problem solve
              • Must have high level of motivation, drive, and demonstration of Takeda's leadership values
              • Excellent written and verbal communication skills
              • Top notch interpersonal skills in difficult situations
              • Ability to work seamlessly with all levels of personnel
              • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
              • Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skillsWHAT TAKEDA CAN OFFER YOUAt Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering Our People to ShineDiscover more at takedajobs.comAt our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have? LocationsZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Rochester , Director, Regulatory Publishing and Submission Management, Executive , Le Roy, New York

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