Regulatory Strategy Lead

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...

**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...

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 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...

About EPM ScientificWe are a biotechnology company focused on developing innovative therapies for rare and underserved diseases. Our mission is to leverage cutting-edge science to target key biological pathways for genetic conditions.Job SummaryThe Director of Regulatory Operations will lead and manage the regulatory strategy and operations for global...

About the RoleWe are seeking a highly skilled Senior Neuroscience Biomarker Strategy Lead to join our team at Takeda Pharmaceutical. As a key member of our Bioanalytical and Biomarker Science and Technologies department, you will play a crucial role in developing and driving translational biomarker strategies for preclinical and clinical programs within our...

**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...

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 SummaryWe are seeking a highly skilled Patient Recruitment Strategy Lead to join our Site and Patient Engagement team within Trial Operations at argenx. As a key member of our global clinical team, you will work closely with leaders to understand patient recruitment needs at a disease and study level and develop effective solutions.Key...

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,...

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...

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...

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...

At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs.About the Role:This highly visible, strategic, and matrixed position is responsible for providing scientific and leadership in developing the translational biomarker strategy for Inflammation and...

Company Overview: Zelis Healthcare, LLC is a leading healthcare technology company that provides innovative solutions to bridge the gaps between payers, providers, and healthcare consumers. With over 750 payers, including top national health plans, BCBS insurers, regional health plans, TPAs, and self-insured employers, as well as millions of healthcare...

Pharmaceutical Technical Leadership RoleThis leadership position plays a pivotal role in shaping the pharmaceutical industry's regulatory landscape. As a Senior Regulatory Expert, you will lead efforts to define and implement external engagement strategies, governance, and associated capabilities for Takeda Pharmaceutical.Key Responsibilities:Develop and...

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...

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...

About Edgewise Therapeutics:Edgewise Therapeutics is a leading biopharmaceutical company focused on developing innovative medicines for serious muscle diseases. Our mission is to improve the lives of patients by harnessing our expertise in muscle biology and biophysics.We are committed to building a strong leadership team with a track record in the...

Job OverviewThis role is responsible for leading a team that provides guidance and oversight for data-related processes. The successful candidate will be responsible for performing business, systems & data analysis around fixed income, managing daily/weekly/monthly production cycles, responding to ad-hoc data analysis requests in support of various projects,...