Regulatory Medical Writing Director

Medical 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...

**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...

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...

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...

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...

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...

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...

Program Director for Medical RadiographyWe are seeking a highly skilled and experienced individual to serve as the Program Director for our Medical Radiography program at Bunker Hill Community College.About the RoleThe Program Director will be responsible for overseeing the overall effectiveness of the Medical Radiography program, including its curriculum...

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...

Job 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...

This role will be responsible for ensuring adherence to global compliance standards and FDA regulations in the creation, review, and approval of advertising and promotional materials.As a Director, Advertising and Promotion Compliance, you will serve as the Regulatory Affairs representative for assigned products and therapeutic areas. You will engage...

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 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...

Director of the Sickle Cell Program OpportunityBoston Medical Center is a leading academic medical center and the primary teaching affiliate of Boston University School of Medicine. We are seeking an exceptional individual to serve as the Director of the Sickle Cell Program.The successful candidate will have expertise in hematology and experience in managing...

About the Role">This role is a key part of Fidelity Digital Asset Services, LLC's Compliance team. As a trusted business partner, you will promote a culture of ethical conduct and commitment to compliance, regulatory, and legal obligations.You will support regulatory oversight of FDAS, collaborating closely with various teams within FDAS and across the...

Key Responsibilities:• Provide medical services, including obtaining medical history and performing physical examinations.• Order laboratory tests, formulate diagnoses, and treatment plans, and prescribe medication as needed.• Assist in surgeries and cover clinic sessions, working with attending physicians to admit, evaluate, treat, and discharge...

Job OverviewAs a Senior Technical Regulatory Advisor at Takeda Pharmaceutical, you will be responsible for defining and implementing an external engagement strategy, governance, and associated capabilities in line with the company's patient-centric values.The role requires strong leadership experience in Quality/Regulatory/Technical areas, with a minimum of...

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...

Boston Medical Center seeks a highly qualified Medical Director for Molecular Hematology to lead clinical testing efforts and develop NGS assays in a CAP-accredited laboratory.As a renowned expert in molecular genetics and hemoglobin diagnostics, you will be responsible for overseeing the development and validation of molecular diagnostics assays,...

Job DescriptionMeet our team and explore the opportunity to support the regulatory process as a Regulatory Affairs Compliance Specialist.We are seeking an experienced professional to manage KPIs, generate reports, and collaborate cross-functionally to ensure compliance with global regulatory requirements.Responsibilities:Collaborate with regulatory teams...