Senior Research Associate GRA CMC

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Job Description

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 Sr associate, Global Regulatory Affairs CMC Submission Management where you will support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned products. Work in alignment with RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.

You will also prepare project plans and timelines for multiple CMC submission activities and be responsible for organization of CMC-related documents for regulatory submissions.  Actively contribute to organizations planned initiatives and projects, lead and manage multiple and simultaneous projects. As part of the Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC and work with the GRA CMC organization.

How you will contribute:

• With supervision, support in executing and managing regulatory tasks for assigned projects (IND/ IMPD/ CTA/ MAA) according to the regulatory strategy laid out by GRA.
• Collaborating with cross-functional teams to develop project plans for global regulatory submissions (IND/ IMPD/ CTA/ MAA) and ensure alignment with business objectives and timelines. 
• Provide guidance to global project teams on submission processes, workflows, tools/ systems, filing strategy, eCTD document lifecycle management.
• Participate to the creation of a submission content plans for assigned projects and monitors’ progress.
• Plan, manage and track delivery of submission components, coordinate submission publishing activities with publishing team, organize submission review and approvals
• Helps to define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
• As a RA CMC member, ensures and/or enhances regulatory compliance.
• Supports project team colleagues, line management, and key stakeholders are informed of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Works effectively with cross-functional teams beyond submission management role, contributing to broader organizational goals and initiatives while engaging in continuous improvement activities to enhance regulatory processes and outcomes leveraging innovative approaches and technologies.
• Collaborates with AI specialists to develop and implement AI-based solutions for regulatory challenges, ensuring alignment with global standards and best practices.
• With supervision, contribute to CMC preparation activities for meetings with Health Authorities on CMC related matters.

Minimum Requirements/Qualifications:

• BS Degree in a science discipline. Advanced degree preferred.
• Pharmaceutical industry experience preferred. 
• 1-2 years of regulatory and/or related experience preferred
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Strong oral and written communications with individuals at all levels of the organization and comfortable presenting to small and large groups.
• Ability to prioritize while managing multiple projects of varied complexity and criticality and to adhere to timelines while demonstrating negotiation skills, integrity and adaptability.
• Demonstrates problem-solving ability with ability to analyze risk, think strategically, and provide appropriate recommendations/decisions. 
• Strong interpersonal skills combined with cultural sensitivity for successful global collaboration.
• Focus on accuracy and strong attention to detail is a must.
• Willingness to provide and receive constructive feedback.
• Project management skills to oversee and coordinate various CMC activities
• Self-motivated, self-starter with the ability to work independently and in a team with a flexible mindset.
• Basic knowledge of tools (e.g., Publishing tools such as CTDxpress, Docubridge); Veeva RIM; global submission validation tools; Document Management systems.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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U.S. Base Salary Range:

EEO Statement

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.

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Job Exempt