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Director, GRA Governance - Remote

Employer
Careerbuilder-US
Location
East Prospect, PA
Closing date
Nov 30, 2022

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Industry
Other
Function
Executive, Management, Director
Hours
Full Time
Career Level
Experienced (Non-Manager)
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 DescriptionThe Regulatory Governance Director ACCOUNTABILITIES Serves as the lead business owner of Regulatory Governance and associated processes and systems. Ensures information and data standards are aligned with Takeda's strategic business requirements (eg MDM, Regulatory strategy, Industry standards, HA expectations)Leads a global team of leaders and regulatory solution professionals.Global SME/Business owner on Data Governance.Enforce and operationalize data governance standardsUnderstands strengths and weaknesses of different data governance model.Connects with the right people to assess the current situation and propose the right strategy.Assess the current data project portfolio, and advises on sequences of operationsWorks as a team with counterparts in Data Sciences and R&DEnsures there is oversight and governance of information and content up and downstream as well as across the governed regulatory systems portfolio.Identify and lead governance related continuous improvement efforts within the regulatory solutions organization.Demonstrates high level of leadership and expert understanding by applying interpersonal skills and expert RA knowledge to address and overcome challenges that arise. Successfully communicates and negotiates with international Health Authorities as necessary, directly or indirectlyEnsures compliance and inspection readiness of regulatory solutions.Ensures that the company's regulatory data are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that relevant information is available for critical business needs and is retained in accordance with established retention schedules.Collaborates with other IM leaders to deliver value-add business facing services to improve system user experience, information accuracy and timelinessEngage and lead with external regulatory forums and consortia on innovation related to solutions and information for the needs of Global Regulatory AffairsEnsures Takeda portfolio support with appropriate SLAs and customer focusLead and define the development and execution of strategic and change management initiatives. Oversees external vendor executing any regulatory governance activities including the development and oversight of robust KPIs.Oversees and mentor direct reports, providing leadership and training to support professional development.Responsible for demonstration of Takeda Leadership behaviors.Technical/Functional (Line) ExpertiseComprehensive understanding of the pharmaceutical industry (eg, clinical development, the prescription drug distribution process, etc)LeadershipDemonstrated ability to work across functions, regions and culturesFunctional level leadership with the ability to inspire, motivate and drive resultsExcellent communicator, able to persuasively convey both ideas and data, verbally and in writingProven skills as an effective team player who can engender credibility and confidence within and outside the companyAbility to distil complex issues and ideas down to simple comprehensible termsDemonstrates leadership presence and confidenceEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizationBuilds 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 AutonomyDecision making responsibilities: Provide input to highly complex decisions that impact the functional areaAccountable for decision making for designated functionAbility to seek diverse input from multiple constituents and stakeholders to drive innovative solutionsAbility 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 scopeInteractionEffectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplaceCultivates 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 mannerAbility to build strong relationships and collaborate effectively with other interfacing Takeda functionsInnovationForward thinking with the ability to recommend, influence and implement organizational change and continuous innovationComfortable challenging the status quo and bringing forward innovative solutionsAbility to take risks implementing innovative solutions, accelerating time to marketIdentifies 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 innovationComplexityAbility to work in a global ecosystem (internal and external) with a high degree of complexityDeep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Bachelor's degree or related experience is required. Scientific or closely related field preferred.10+ years of experience in Pharmaceutical industry, with 10 years in Regulatory Affairs, research and development, quality assurance/compliance.Demonstrated experience leading teams, managing and mentoring colleagues.Significant experience in global drug development regulations, regulatory submissions, lifecycle manage-ment, compliance, business systems technology and process is required.Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and industry forums, international experience preferred.Expert understanding of scientific principles and regulatory information standards/requirements relevant to global drug development and post-market support. Understanding in regulatory publishing and Information management tools is required.Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.Demonstrates high level of leadership, problem-solving ability, flexibility and teamwork.Exercises good judgement in elevating and communicating actual or potential issues to line management.Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums expected. Recognized as an expert in the field.EEO StatementTakeda 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.LocationsUSA - MA - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

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