at Takeda Pharmaceuticals in Montpelier, Vermont, United States
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.
Join Takeda as a Director, Regulatory Information Management, GRA where you will provide leadership, strategic thinking and expert execution for the Information Management portfolio and associated information repositories serving Global Regulatory Affairs organization and business processes. Incumbent will partner with business stakeholders. You will also liaise with Takeda Digital to ensure activities are implemented to plans with Information integrity and according to defined requirements and timelines. As part of the Regulatory Information Management and Digital Innovation, you will report to the Head, Regulatory Information Management and Digital Innovation.
How you will contribute:
+ Serve as the lead business owner of Regulatory Information Management (RIM) and associated processes and systems. Ensures information and data standards are aligned with Takeda’s strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations)
+ Lead a global team of leaders and regulatory solution professionals.
+ Provide strategic direction and tactical management of all regulatory automation solutions.
+ Ensures appropriate enterprise information and solution integration points for consistent and compliant data flow.
+ Partner closely with Digital to ensure fully integrated regulatory systems, experience and information model and externally facing capabilities.
+ Ensure there is strategy and implementation plan for seamless integration of information and content up and downstream as well as across the governed regulatory systems portfolio.
+ Lead and maintain a collaborative program of continuous improvement within the regulatory solutions organization.
+ Demonstrates high level of leadership and expert understanding of global RA information/data set regulations and guidelines 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 indirectly
+ Oversees day-to-day GRA RIM initiatives (integration, acquisitions/divestitures, IDMP, xEVMPD, SPOR, MDM).
+ Ensure compliance and inspection readiness of regulatory solutions.
+ Ensure that the company’s regulatory information and records 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 timeliness
+ Engage and lead with external regulatory forums and consortia on innovation related to solutions and information for the needs of Global Regulatory Affairs
+ Ensure Takeda portfolio support with appropriate SLAs and customer focus
+ Lead and define the development and execution of strategic and change management initiatives.
+ Oversee outsourcing activities performed by external vendor(s) for the management of regulatory information including the development and oversight of robust KPIs and the oversight of vendor activities for RIM system maintenance.
+ Oversees and mentor direct reports, providing leadership and training to support professional development.
+ 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 management, 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.
What Takeda can offer you:
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs and company match of charitable contributions
+ Family Planning Support
+ Flexible Work Paths
+ Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as “hybrid” or “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda 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.
USA – MA – Virtual
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