Regulatory Affairs Specialist

Job Title: Regulatory Affairs StrategistWe are seeking a skilled Regulatory Affairs Strategist to join our team at Apogee Therapeutics. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's regulatory strategies and ensuring compliance with US and international regulations.About Apogee TherapeuticsApogee...

About the RoleAt Lifelancer, we are looking for a highly skilled Regulatory Affairs Operations Manager to support our clients in the biotechnology and pharmaceutical industry. As a key member of our team, you will be responsible for coordinating and preparing regulatory submissions to health authorities, including FDA, EMA, and other national...

Job SummaryWe are seeking an experienced CMC Regulatory Affairs leader to join our team at Apellis, a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds.This leadership role will oversee the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) submissions in...

Unlock Your Career in Biotech Regulatory AffairsA dynamic opportunity awaits at Apogee Therapeutics, a well-funded biotechnology company pioneering innovative treatments for inflammatory and immunology indications.The ideal candidate will possess a strong background in regulatory affairs, with a minimum of 4 years of experience working in drug development in...

About the RoleAt BostonGene, we are seeking an experienced Regulatory Manager to play a pivotal role in ensuring our ISO certification efforts and regulatory compliance.ResponsibilitiesDevelop and implement regulatory strategies and processes to guarantee compliance with ISO standards and Good Laboratory Practice (GLP) requirements.Provide strategic and...

OverviewGlobal Partners LP is a leading energy company with a rich history of delivering value to our customers and communities. We are seeking a highly skilled Government Affairs Manager to join our team and play a critical role in advancing our legislative and political agenda.Estimated SalaryWe offer a competitive salary range of $120,000 - $160,000 per...

**Job Overview**Precision Life Sciences is seeking a highly skilled Senior Validation Specialist to join our team.**Salary:** $95,000 - $115,000 per yearAs a Senior Validation Specialist at Precision Life Sciences, you will play a key role in ensuring the quality and compliance of our computer systems and equipment. We are looking for a motivated and...

Sequoia Biotech Consulting is a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. We are seeking a highly skilled Validation Engineer to join our team.About UsWe provide fully integrated solutions across the development...

Lead a Team in Ensuring Regulatory ComplianceWe are seeking an experienced Executive Director of Quality Assurance and Compliance to lead our quality team in ensuring regulatory compliance across all aspects of our operations.About the Role:Develop and implement a comprehensive quality strategy that aligns with our commercialization goals and global...

Role OverviewWe are seeking a Director of Quality Control to lead our Quality organization in ensuring compliance with regulatory standards and driving quality initiatives.About the RoleThe ideal candidate will have a strong background in GxP quality systems, risk management, and continuous improvement. They will be responsible for developing and executing a...

Spyre Therapeutics, a clinical-stage biotechnology company, seeks a Senior Director of Immunology and Inflammation Clinical Development to lead the clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications.This role requires strong leadership and medical expertise to provide strategic guidance...

About the role: Job OverviewIn this position, you will be working as a key member of our Healthcare Compliance team. The main responsibility is to assist the Associate Director of Healthcare Compliance with activities related to data collection, validation, and submission in compliance with federal and state transparency reporting laws and regulations.

Job DescriptionPosition OverviewAs Manager of the statistical team at Paragonix Technologies, Inc., you will lead and support all statistical and programming activities. This role will work with Scientific and Medical Affairs management, responsible for oversight of the design, validation, analysis and interpretation of clinical data from multiple registries...

About UsAt Skanska, we're shaping the way people live, work, and connect. As one of the world's largest development and construction companies, we bring over 135 years of expertise to every project.Job SummaryWe're seeking a highly skilled Project DBE Compliance Specialist to join our team in [location]. This is an exciting opportunity to be part of a...

Job OverviewParagonix Technologies, Inc. is a pioneering company in the field of organ transplantation. We are seeking an experienced Organ Preservation Specialist to join our team.Key ResponsibilitiesWe are offering a competitive salary range of $120,000 - $180,000 per annum.Support the development and commercialization of innovative products designed to...

Are you passionate about protecting human subjects and ensuring the integrity of research?About the RoleWe are seeking a highly skilled and detail-oriented Research Compliance Specialist to join our Human Research Protection Program team at Brandeis University.Job DescriptionThis is a part-time position working 17.5 hours per week. The Research Compliance...

Apellis Pharmaceuticals - A Global Leader in BiopharmaceuticalsAt Apellis Pharmaceuticals, we are committed to developing innovative therapies for challenging diseases. As a Senior Manager/Associate Director, Commercial Engagement Specialist, you will play a critical role in building and nurturing strategic relationships with key opinion leaders (KOLs) in...

Job OverviewWe are seeking a highly skilled Senior Biostatistics Manager to lead our clinical data analysis team at Paragonix Technologies, Inc. in Waltham, MA.Job Responsibilities:Oversee the design, validation, analysis, and interpretation of clinical data from multiple registries to support product development and business objectives.Manage a team of...

Company Overview:Entegee specializes in custom automation projects, leveraging expertise in controls and robotic solutions to deliver innovative results. Our team collaborates with clients to understand their unique needs and develops tailored solutions that drive success.Salary:$38-$48 per hourJob Description:We are seeking an experienced Electrical...

Job Summary: We are seeking an experienced Pediatric Mental Health Specialist to join our team at Boston Children's Hospital. As a key member of our Inpatient Psychiatry Service, you will provide high-quality psychiatric care to pediatric patients with severe psychiatric disorders and co-morbid medical conditions. About the Role: This is a challenging yet...