Director of Regulatory Affairs, CMC
1 week ago
Takeda Pharmaceutical is a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients. We are seeking a skilled Director of Regulatory Affairs, CMC to oversee the development and execution of regulatory CMC strategies for small molecules.
The successful candidate will have extensive experience in pharmaceutical regulatory affairs, with a proven track record of providing strategic guidance on regulatory matters and making informed decisions. Strong leadership skills, problem-solving abilities, and flexibility to adapt to changing project needs are also essential.
This position involves working closely with cross-functional teams, including regulatory agencies, and requires strong communication and negotiation skills. The successful candidate will be responsible for ensuring compliance with global regulations and maintaining constructive relationships with key internal and external stakeholders.
As part of our team, you will enjoy a competitive $173,100 - $272,300 salary range, along with opportunities for professional growth and development. If you are passionate about regulatory affairs and leading high-profile projects, we invite you to apply for this challenging opportunity.
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CMC Regulatory Affairs Director
5 days ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the Role:Takeda Pharmaceutical is seeking a highly skilled CMC Regulatory Affairs Director to oversee the development and execution of regulatory strategies for pharmaceutical products. As a key member of the Global Regulatory Affairs team, you will be responsible for ensuring compliance with global regulations and guidelines.The ideal candidate will...
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Regulatory Affairs Leader
2 weeks ago
Étreux, Hauts-de-France, United States Albion Rye Associates Full timeAbout Albion Rye AssociatesWe are a cutting-edge pre-clinical biotechnology company dedicated to developing innovative small-molecule therapies to address unmet medical needs. Our mission is to translate groundbreaking science into transformative therapies for patients worldwide.Job Title: Director of Regulatory AffairsThis is an exciting opportunity for a...
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Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full timeJob SummaryThe Chemistry Manufacturing Controls Senior Manager will play a critical role in executing global regulatory CMC strategies for investigational and marketed products. This position is responsible for leading the preparation and submission of regulatory CMC documentation, managing interactions with Health Authorities, and providing regulatory...
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Regulatory Affairs Director
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time**Job Description:**We are seeking an experienced Regulatory Affairs Director to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success...
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Regulatory Affairs Director
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Regulatory Affairs Director
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Étreux, Hauts-de-France, United States Albion Rye Associates Full timeAlbion Rye Associates is seeking a highly experienced Regulatory Affairs professional to lead our regulatory strategy and guide us through key regulatory milestones.The ideal candidate will have a strong background in FDA regulatory submissions, a comprehensive understanding of the biotechnology regulatory landscape, and an established record of working with...
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Associate Director, Regulatory Affairs Lead
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Biotechnology Regulatory Affairs Executive
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeJob OverviewThe role of Senior Regulatory Affairs Expert, Labeling Compliance Specialist at Takeda Pharmaceutical is a pivotal position that ensures the company's products meet regulatory requirements and maintain compliance with global labeling standards.This position plays a crucial role in ensuring Takeda gains regulatory approval for new products and...
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Regulatory Affairs Specialist
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Global Regulatory Affairs Transformation Leader
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeTransformative Leadership OpportunityTakeda Pharmaceutical is seeking an exceptional Global Regulatory Affairs Transformation Leader to spearhead the development of a best-in-class Regulatory Operations organization.The successful candidate will be responsible for envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the...
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Cell Therapy Program Lead
2 weeks ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeTakeda Pharmaceutical is seeking an experienced professional to fill the role of Cell Therapy Program Lead - CMC. As a member of our Cell Therapies CMC team, you will play a critical role in developing and implementing CMC strategies for allogeneic cell therapies. This position offers a unique opportunity to leverage your technical expertise, leadership...
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CMC Cell Therapy Development Manager
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeWe are currently seeking a seasoned professional to fill the role of CMC Cell Therapy Development Manager at Takeda Pharmaceutical. In this position, you will have the opportunity to leverage your technical expertise, leadership skills, and strategic thinking to drive the development and implementation of cutting-edge CMC strategies for allogeneic cell...
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Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full timeDevelop a Strategic State Government Affairs StrategyAs a seasoned State Government Affairs Director at Vertex Pharmaceuticals, you will play a pivotal role in developing and implementing the company's state/regional government affairs and public policy strategy. This critical position will work closely with various functional areas to lead the company's...
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Oncology Regulatory Affairs Manager
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeWe are seeking an experienced Oncology Regulatory Affairs Manager to join our team at Takeda Pharmaceutical. As a key member of our global regulatory team, you will play a crucial role in ensuring the success of our oncology products through effective regulatory strategy and execution.In this role, you will be responsible for developing and implementing...
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Senior Regulatory Lead
2 weeks ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the Opportunity:Takeda Pharmaceutical is seeking a highly skilled professional to fill the role of Senior Director, Global Regulatory Lead, GI & Inflammation. This position offers an exciting opportunity to work with a dynamic team, develop innovative solutions, and contribute to the company's mission of improving patient lives.The ideal candidate will...