Associate Director, GRA Regional Compliance - ICMEA, Russia

Company: Takeda Pharmaceutical
Location: Rockledge
Posted on: November 25, 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 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.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as -an Associate Director, GRA Regional Compliance - ICMEA, Russia, based -in Zurich. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVES: -

• Provide direction and leadership in the identification, creation, and execution of GRA Compliance initiatives to drive overall compliance and growth, within Regional and Local Operating Companies (LOCs), while meeting Takeda corporate objectives.
• Responsible for overseeing with the regions/LOCs, updates and maintenance of systems linked to regulatory activities e.g., Regulatory Information Management System, including the timeliness, quality and accuracy of information.
• Oversees the implementation of GRA processes, systems and procedures for GxP processes (e.g. change control, deviations/CAPAs, etc.) within the region/LOC ensuring execution and compliance.
• Provides direction and oversight in the management of submissions and submission activities within the regions/Local Regulatory Affairs in accordance with local regulations
• Responsible for overseeing global regulatory compliance metrics at a country/regional level
• Oversight of audits and inspections related to Regulatory affairs processes globally within the regions/LOCs
• Partners and provides direction with the Regulatory Area Heads on key Regulatory strategic initiatives and/or issues
• Partner effectively with cross functional teams, in the proactive identification of key regulatory compliance issues to determine actionable project proposals and drives them to successful resolutionACCOUNTABILITIES: -
  • Responsible for demonstrating Takeda leadership behaviors.
  • Lead critical GRA projects for GRA Compliance for both strategic and operational organization, compliance and effective implementation
  • Drives compliance within the LOCs linked to regulatory submissions including the updating and maintenance of systems used for regulatory activities
  • Monitors global regulatory compliance performance within LOC RA and takes action to address issues within LOC or in GRA
  • Oversees the development, implementation and understanding of regional and local RA training materials related to global regulatory processes/systems. Delivers training as needed
  • Oversees the update and management of all regional/Local Information/access sites/portals/distributions; and facilitate creation, implementation and maintenance of communications and effective change management of RA processes in region/LOCs.
  • Oversees inspection and audit activities within the region/LOC RA. Monitors trends and looks for opportunities to ensure audit and inspection readiness
  • Develop strong partnerships with cross functional leadership within the region and LOCs.
  • Lead and engage in efforts to simplify and optimize business processes and platforms to drive growth and seeks opportunities for automation of manual processesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
    • Bachelor's Degree in a science or business-related field.
    • 8+ years of experience in pharmaceutical industry, with 6 years in Regulatory Affairs, research and development, quality assurance/compliance
    • People management skills
    • Familiarity with Regulatory systems
    • Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
    • Demonstrated knowledge of health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices in applicable regions.
    • Practical operational experience of working across disciplines and across multiple regions. - Experience working within a global team framework and a multi-cultural environment. -
    • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
    • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
    • Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
    • Excellent analytical, technical and problem-solving skills
    • Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
    • Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. - -
    • Excellent organizational skills and ability to prioritize as well as Project Management abilities.WHAT 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, Melbourne , Associate Director, GRA Regional Compliance - ICMEA, Russia, Executive , Rockledge, Florida