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Executive Director, Global Regulatory Affairs CMC Early Development

Boston, Massachusetts

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Today

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Executive Director, Global Regulatory Affairs CMC Early Development Are you looking for a patient-focused company that will inspire you and support your career?

Full-time

Compensation information provided in the description

Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product

Boston, Massachusetts

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Today

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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

Full-time

Compensation information provided in the description

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Boston, Massachusetts

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Today

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Job Description Objective / Purpose Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development a

Full-time

Compensation information provided in the description

CMC Regulatory Affairs - Small Molecule

Remote

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Today

Job Title: CMC Regulatory Affairs Specialist/Manager Small Molecules Location: Remote Experience: 10+ Years Job Summary We are seeking an experienced CMC Regulatory Affairs professional with expertise in small molecule drug development to support global regulatory submissions and lifecycle management activities. The candidate will be responsible for preparing, reviewing, and managing Chemistry, Manufacturing, and Controls (CMC) regulatory documentation for investigational and marketed products.

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Contract, Third Party

Depends on Experience

CMC Regulatory Affairs Specialist Small Molecules

Remote

•

Today

Job Title: CMC Regulatory Affairs Specialist - Small Molecules Location: Remote Job Summary: Responsible for preparing and managing CMC regulatory submissions for small-molecule drug products, ensuring compliance with global regulatory requirements. Key Responsibilities: Prepare and review CMC sections for IND, NDA, ANDA, and MAA submissions Author Module 3 (Quality) documents in eCTD format Ensure compliance with FDA, EMA, Health Canada, and ICH guidelines Support manufacturing, analytic

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Third Party, Contract

CMC Regulatory Affairs Specialist

Remote

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Today

Role: CMC Regulatory Affairs Specialist Location: Avenel, New Jersey -WFH Duration: 12+ Months Must Have Chemistry Manufacturing Controls (CMC) Responsibilities: Develop and implement compliance policies and procedures.Monitor and evaluate compliance with regulations and standards.Conduct internal audits to identify compliance issues.Provide guidance and training on regulatory compliance to staff.Coordinate responses to regulatory inquiries and audits.Stay current on regulatory changes and ind

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Contract

Depends on Experience

CMC Regulatory

Remote

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Today

Job Title: Regulatory Affairs - Operations Specialist Location: New Jersey, NJ (Remote) Duration: 6-12 Months Job Description: Must Have: Chemistry Manufacturing Controls (CMC) Develop and implement compliance policies and procedures.Monitor and evaluate compliance with regulations and standards.Conduct internal audits to identify compliance issues.Provide guidance and training on regulatory compliance to staff.Coordinate responses to regulatory inquiries and audits.Stay current on regulatory ch

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Third Party, Contract

Depends on Experience

Application Development Specialist, CMC

Remote or Rochester, New Hampshire

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Today

Job Purpose: Directly contributes to the execution of AEC's strategic plans and overall growth of AEC by being a primary interface for Engineering, R&T and AEC's Business Development organization to drive insertion of ceramic matrix based composite materials and emerging technologies into production applications. This individual will identify and drive internal and customer facing activities to accelerate AEC's profitable growth through technology differentiation. Achieving this requires establi

Full-time

Executive Director, Regional External Innovation Lead

Waltham, Massachusetts

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Today

CSL\'s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we?re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Executive Director, Regional External Innovation and Due Diligence Lead? The job is in our Waltham MA Office. This is a

Full-time

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