Regulatory Operations Lead for Global Submissions

Senior 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...

We are a patient-focused company that strives for excellence in everything we do. At Takeda Pharmaceutical, we unlock innovation and deliver transformative therapies to patients worldwide.About the RoleAs a Senior Director, Global Regulatory Lead, GI & Inflammation, you will define, develop, and lead global strategies to maximize regulatory success towards...

About the RoleWe are seeking a highly skilled Senior Manager to lead our global regulatory efforts in the GI and Inflammation department at Takeda Pharmaceuticals.As a key member of our team, you will oversee and execute all regulatory activities for multiple projects, including one highly complex project in development. Your expertise will be crucial in...

**Job Summary:** We are seeking an experienced Lead Regulatory Expert 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 for...

Albion 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...

Job Overview:The Regulatory Compliance Lead for Global Labeling Initiatives will play a pivotal role in ensuring Takeda Pharmaceutical's products gain regulatory approval across the globe while maintaining currency of product licenses and permits. This senior position contributes to the company's mission by guaranteeing compliance with legislation and...

**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...

About the RoleWe are seeking an experienced Director of Global Regulatory Strategy to lead our regulatory affairs efforts and establish a global strategy for multiple BLA programs.Company OverviewTrebla Talent is a pre-IPO, clinical-stage biotech company specializing in novel immunotherapies for cancer and autoimmune diseases. Our team is dedicated to...

Transformative 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...

Job 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...

Senior 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...

About the Role:Takeda Pharmaceutical is a global leader in transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a highly skilled Regulatory Strategy Lead to join our team.This is a senior leadership position that requires expertise in developing and implementing global regulatory...

Job 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...

Position 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,...

About UsTakeda Pharmaceutical is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices.Job DescriptionThe Associate Director, Global Labeling Lead will be responsible for the development...

Planet Pharma is seeking an experienced Associate Director of Regulatory Medical Writing to join their team. This role offers a competitive salary range of $140,000 - $180,000 per annum.This individual will contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. They will also develop critical...

Role OverviewWe are seeking a highly skilled Regulatory Expert to join our team in Boston, MA. As a key member of our regulatory department, you will play a critical role in the development and implementation of innovative device and integral/co-packaged combination product regulatory strategies.About UsTakeda Pharmaceutical is a world-class R&D organization...

Job Summary:We are seeking a highly experienced and skilled Optimize Global Operations Lead to join our MassMutual team. This pivotal role requires a strong background in process improvements, operational excellence, and leadership skills.About the Role:The successful candidate will lead large-scale transformation initiatives across our organization, driving...

Actalent: A Global Leader in Engineering and Sciences ServicesWe are seeking an experienced Global Drug Safety Operations Manager to join our team. The successful candidate will play a pivotal role in driving the success of our drug safety activities.About the RoleAs a Global Drug Safety Operations Manager, you will be responsible for ensuring that all drug...

Veeva Systems is a leader in industry cloud solutions, empowering life sciences companies to accelerate their mission to bring therapies to patients faster. With a strong focus on customer success and employee growth, we strive to create a positive impact on our customers, employees, and communities.Company OverviewWe are a Work Anywhere company, offering...