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Are you looking for a Director, Global Regulatory Affairs CMC Business Process Excellence? We suggest you consider a direct vacancy at Takeda Pharmaceutical in Hillsdale. The page displays the terms, salary level, and employer contacts Takeda Pharmaceutical person

Job opening: Director, Global Regulatory Affairs CMC Business Process Excellence

City: Hillsdale
Published at: May 26 2023
Employment Type: Full-Time
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 DescriptionAbout 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, Global Regulatory Affairs (GRA) CMC Business Process Excellence, where you will lead GRA CMC process excellence in GRA and in partnership with organizational and external stakeholders. You will also develop processes/best practices that enable seamless integration of CMC activities and documentation for original and lifecycle CMC submissions. As part of the Global Regulatory Affairs CMC team, you will report to the Head of Global Regulatory Affairs CMC - Business Process, Process Excellence & Systems and work with Pharmaceutical Sciences, Global Manufacturing Services and Global Quality.How you will contribute:Demonstrate Takeda leadership behaviors.Develop and oversee development (including updates) and communication of tools, best practices, and updates to systems to global CMC regulatory teams and stakeholders in a timely mannerDevelop a team of experts capable of enabling both the pipeline and maintenance of products through active engagement with stakeholders to develop efficient and effective practices that use digital as the framework and promote continuous improvement.Build and manage relationships through active partnering with key internal (GRA, GRA CMC, Pharm Sci, GMS, GQ etc.) and external stakeholdersDisseminate tools, processes, system updates to staff and stakeholders through team sites or intranet. Engage and influence organization to think proactively and use digital strategies to promote continuous improvement.Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.Together with the team, develops tools and best practices that allow GRA CMC product Leads to provide consistent input to GRL''s GPT''s and other stakeholders across the organization.Minimum Requirements/Qualifications:Bachelor''s Degree in a Scientific Discipline with 10+ years of relevant professional experience.Prior industry experience with regulatory business processes, systems and best practices development and implementation preferred.End-to-end enterprise-wide basic understanding of global drug development and post-market support with ability to support to lifecycle teams.Deal with issues of critical importance, provides advice and makes reasoned recommendations/decisions on regulatory processes and toolsDemonstrate leadership, problem-solving ability, flexibility, and teamwork.Exercise good judgement in elevating and communicating actual or potential issues to line management.Excellent written and oral communication skills required.What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportFlexible Work PathsTuition reimbursementMore 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'' 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.LI-LC1EEO 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time