Regulatory Affairs Director CMC

Job OverviewSolid Biosciences is a dynamic and innovative biotechnology company seeking an experienced Senior Director of Regulatory CMC to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and tactical support to our development and CMC teams.

Job SummaryWe are seeking a highly skilled Senior Manager of Regulatory CMC to join our team at Solid Biosciences in Charlestown. This is an exciting opportunity to work in a dynamic and innovative environment and to contribute to the development of life-changing gene therapies.The successful candidate will be responsible for developing and implementing...

Job DescriptionAs a Senior Director of Regulatory CMC at Solid Biosciences, you will oversee the preparation of high-quality global clinical trial applications, including CMC content for INDs/CTAs and amendments. You will also coordinate and drive regulatory submissions, work closely with technical teams to implement manufacturing and analytical strategies,...

About Solid BiosciencesSolid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs. We are seeking an experienced Senior Manager of Regulatory CMC to join our team.ResponsibilitiesContribute to the development and implementation of global regulatory CMC strategies.Prepare and submit high-quality...

About the RoleWe are seeking a highly skilled Senior Manager of Regulatory CMC to join our team at Solid Biosciences in Charlestown. The ideal candidate will have a strong background in regulatory affairs, particularly in gene therapy development, and be able to work effectively in a collaborative team environment.The successful candidate will be responsible...

Key Responsibilities:Develop and execute the bioanalytical assay strategy for clinical programs, ensuring that all assays meet clinical, regulatory, and scientific requirements.Ensure that bioanalytical assays are validated according to relevant regulatory guidelines (FDA, EMA) and Good Laboratory Practices (GLP), providing assay documentation to support...

Program DirectorWe are seeking a highly experienced and skilled Program Director to lead our team at Behavioral Health Network.About the Role:The Program Director will provide clinical and administrative leadership, overseeing marketing and advocacy efforts, identifying program outcomes, and ensuring regulatory compliance. This is an exciting opportunity to...

About the RoleThe Senior Governance, Risk, and Compliance Analyst will play a critical role in fostering a culture of compliance and risk awareness across the organization. This position offers an exciting opportunity to work closely with various departments to ensure our policies and procedures are in line with industry standards and regulatory...

Job DescriptionJob DescriptionJob Title: Director/Sr Director, Regulatory CMCReports to: Chief Regulatory OfficerSummary:Solid Biosciences is seeking a Director/Sr. Director of Regulatory CMC based in Charlestown (with a hybrid option). We are seeking a creative and agile regulatory professional who is eager to be a part of a collaborative team with a goal...

Job DescriptionJob DescriptionJob Title:Manager/Senior Manager, Regulatory CMCReports to (title):Chief Regulatory OfficerSolid Summary:Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene...

Job DescriptionJob DescriptionJOB SUMMARY: As a member of CareQuest Institute’s Legal Department, the Associate General Counsel is a strategic thinker and business partner who provides practical, real world legal solutions and works collaboratively with other teams at CareQuest Institute and its affiliates. The Associate General Counsel is responsible for...

Job DescriptionJob DescriptionReporting to the Director, Governance, Risk, and Compliance, the Senior Governance, Risk, and Compliance (GRC) Analyst will be responsible for supporting and managing GRC initiatives within our organization. This role requires a deep understanding of regulatory requirements, risk management frameworks, and compliance best...

Description: GENERAL SUMMARY/ OVERVIEW STATEMENT: Under the direct supervision of the Director of the Institute for Innovation in Imaging, the Nuclear Pharmacist will be part of our growing radiopharmaceutical production program. In alignment with existing facilities, this radiopharmaceutical production facility focuses on fluorine-18, gallium-68 and...

GENERAL SUMMARY/ OVERVIEW STATEMENT: Under the direct supervision of the Director of the Institute for Innovation in Imaging, the Nuclear Pharmacist will be part of our growing radiopharmaceutical production program. In alignment with existing facilities, this radiopharmaceutical production facility focuses on fluorine-18, gallium-68 and copper-64 based...

Mass General Brigham is seeking a Pharmacist for a job in Charlestown, Massachusetts. Job Description & Requirements Specialty: Pharmacist Discipline: Allied Health Professional Duration: Ongoing 40 hours per week Shift: 8 hours, days Employment Type: Staff At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member...

Description: GENERAL SUMMARY/ OVERVIEW STATEMENT: Under the direct supervision of the Director of the Institute for Innovation in Imaging, the Nuclear Pharmacist will be part of our growing radiopharmaceutical production program. In alignment with existing facilities, this radiopharmaceutical production facility focuses on fluorine-18, gallium-68 and...

Mass General Brigham is seeking a Social Work Social Worker for a job in Charlestown, Massachusetts.Job Description & RequirementsSpecialty: Social WorkerDiscipline: Social WorkDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: StaffAt Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings...

Mass General Brigham is seeking a Social Work Social Worker for a job in Charlestown, Massachusetts.Job Description & RequirementsSpecialty: Social WorkerDiscipline: Social WorkDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: StaffAt Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings...

Mass General Brigham is seeking a Social Work Social Worker for a job in Charlestown, Massachusetts.Job Description & RequirementsSpecialty: Social WorkerDiscipline: Social WorkDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: StaffAt Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings...