Senior Regulatory Affairs Manager
6 days ago
We are seeking a highly experienced Regulatory Affairs Manager to join our team at Jobot, a leading consulting firm in the medical device industry.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with FDA and other relevant regulatory requirements.
- Manage quality assurance processes, including audits, corrective actions, and quality control systems.
- Lead a team of regulatory professionals, providing guidance and support for their continued development and success.
- Liaise with regulatory bodies and external stakeholders on all regulatory matters.
- Review and approve regulatory submissions to ensure accuracy and completeness.
- A bachelor's degree in a scientific discipline; an advanced degree is preferred.
- A minimum of 3-5 years of experience in regulatory affairs in the medical device industry, including experience with FDA regulations.
- Proven leadership skills with experience managing a small team.
- Excellent knowledge of regulatory requirements and quality assurance principles.
We offer a competitive salary package of $100,000 - $125,000 per year, depending on experience. This includes a comprehensive benefits package, opportunities for growth and development, and a chance to work in multiple therapeutic areas.
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Étreux, Hauts-de-France, United States Monte Rosa Therapeutics Full timeJob SummaryWe are seeking a highly skilled and self-motivated regulatory professional to join our team as a Senior Manager, Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas.The successful candidate will be responsible for developing and implementing regulatory strategies to support the global development and...
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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 Director
4 weeks ago
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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Senior Regulatory Affairs Specialist
1 day ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout TakedaCompany OverviewTakeda Pharmaceutical is a global leader in the development and commercialization of innovative medicines, driven by our commitment to patients and our values. We strive to be at the forefront of the biopharmaceutical industry, leveraging cutting-edge technologies and expertise to deliver transformative therapies that improve the...
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Global Regulatory Affairs Transformation Leader
3 weeks ago
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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Biotechnology Regulatory Affairs Executive
4 weeks ago
Étreux, Hauts-de-France, United States Monte Rosa Therapeutics Full timeSenior Regulatory Professional for Innovative TherapiesMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas.The successful candidate will be responsible for developing and...
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Regulatory Affairs Director
3 weeks ago
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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Oncology Regulatory Affairs Manager
3 days ago
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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CMC Regulatory Affairs Director
3 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 Specialist
6 days ago
Étreux, Hauts-de-France, United States Proclinical Staffing Full timeProclinical Staffing is a dynamic startup focused on developing innovative diagnostic tools for healthcare.We are seeking a hands-on Regulatory Affairs Manager with a strong background in medical devices, particularly SaMD (Software as a Medical Device).The role is crucial for ensuring our products meet all regulatory requirements and standards.You will be...
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Director of Regulatory Affairs, CMC
1 week ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda 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...
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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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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...
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Regulatory Affairs Director for Medical Devices
4 weeks ago
Étreux, Hauts-de-France, United States Proclinical Staffing Full timeMedical Device Regulatory Expert WantedWe are seeking a seasoned Regulatory Affairs Manager to join our team in Boston, MA. This role is crucial for ensuring our medical devices meet all regulatory requirements and standards.About the RoleThis is an exciting opportunity for a hands-on professional with a strong background in medical devices, particularly...
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Associate Director, Regulatory Affairs Lead
3 weeks ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout Our CompanyWe are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.Job SummaryThe Associate Director, Global Labeling Lead will oversee the development...
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Regulatory Affairs Director
4 weeks ago
Étreux, Hauts-de-France, United States Revvity Full timeJob Title: Regulatory Affairs Director - AmericasAbout the Role:Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from...
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout Takeda PharmaceuticalTakeda is a patient-focused company dedicated to delivering innovative therapies and unparalleled support programs.At Takeda, we are transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs.Job SummaryWe seek a highly skilled Regulatory Affairs Manager to lead the development of...
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Director of Quality and Regulatory Affairs
6 days ago
Étreux, Hauts-de-France, United States Disability Solutions Full timeJob Overview:We are seeking a highly experienced Senior Director, Quality Assurance to lead the development and implementation of a comprehensive quality strategy for a new portfolio of assay products at Disability Solutions.The successful candidate will have a strong background in medical device and lab developed tests or digital product,...
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Regulatory Affairs Strategist
4 weeks ago
Étreux, Hauts-de-France, United States Meet Full timePosition OverviewWe are seeking a highly experienced Regulatory Affairs Strategist to drive regulatory strategy for our anti-infective portfolio through all development phases.This role involves co-leading a US NDA with a cross-functional project team and serving as the primary liaison with the FDA. The ideal candidate will have strong communication,...
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Global Regulatory Operations Visionary
3 weeks ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeSenior Regulatory Affairs Leadership OpportunityWe are seeking a highly experienced and visionary leader to head our Global Regulatory Operations team at Takeda Pharmaceutical. As a key member of our senior leadership team, you will be responsible for driving the development and implementation of our regulatory strategy, ensuring compliance with global...