CMC Regulatory Affairs Leader

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...

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...

Are you a skilled Regulatory Affairs Specialist looking to make a significant impact in the Life Sciences industry?Lifelancer is seeking a highly experienced professional to join our team as a Senior Regulatory Affairs Specialist. This role offers the opportunity to work on high-profile projects, collaborate with cross-functional teams, and contribute to the...

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...

About the Role:We are seeking a highly skilled Pharmaceutical Project Manager to join our team at Upstream Bio. This is an excellent opportunity for a professional with experience in CMC project management to advance their career and contribute to the development of verekitug, a groundbreaking treatment for severe asthma and chronic rhinosinusitis with nasal...

Company Overview: Global Partners LP has been a leading provider of energy solutions for over 90 years. Our integrated network of businesses delivers value to our guests and customers across the US.About the Role: We are seeking a highly skilled Strategic Government Affairs Lead to advance our legislative and political agenda. This individual will develop...

Job Overview:This position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative team.Primary Responsibilities:Lead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods following...

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...

About the RoleWe are seeking a highly experienced Senior Project Manager to join our team at Apellis Pharmaceuticals. As a key member of our Technical Operations department, you will be responsible for managing complex projects from inception to delivery.Job DescriptionProject ManagementDevelop and execute project plans, ensuring timely completion and within...

Mass General Brigham is seeking a dedicated Psychiatric Nurse to lead patient care in Waltham, Massachusetts.About the RoleThis ongoing nursing position requires 40 hours of work per week with an 8-hour evening shift. As a Psychiatric Charge Nurse, you will utilize the nursing process to provide immediate and long-term care needs of patients within the...

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...

Unlock Career Growth in a Thriving Biopharmaceutical CompanyWe are Deciphera Pharmaceuticals, a leading biotech firm dedicated to revolutionizing cancer treatment through innovative medicines. Our team is passionate about making a difference in the lives of patients and families affected by this disease.About the Role:We seek a Senior Manager, Clinical...

Job OverviewThe Senior Medical Director, Oncology Drug Safety Leader role at Mythic Therapeutics is a high-profile position that requires exceptional leadership and expertise in drug safety. As a key member of the Product Development Team (PDT), you will be responsible for ensuring the safe development and delivery of novel antibody drug conjugates (ADCs) to...

Seize the Opportunity to Lead the Next Frontier in Cancer ResearchBostonGene Corporation is a pioneer in biomedical software for advanced patient analysis and personalized therapy decision-making in cancer treatment. Our innovative solution integrates cutting-edge cancer research and clinical data to empower clinicians in tailoring optimal treatment...

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...

We are a pioneering FinTech company, leading the charge in software innovation within the financial sector. Our mission is to transform risk assessment in financial decision-making, making it smarter, faster, and more efficient for institutions globally.About UsWe're a cutting-edge company revolutionizing the financial world with our advanced SaaS tools. Our...

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...

**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...