Regulatory Affairs Specialist II/Sr.

Job Description: The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-functional development teams to assist in the development, communication, and execution of regulatory strategy and submission timelines. Manage document and submission preparation and timelines for regulatory submissions to the FDA, including...

Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...

Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...

Job DescriptionThe Opportunity We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role...

Job DescriptionJob DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across...

Job DescriptionJob DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across...

Vigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...

Vigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...

Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

Job DescriptionJob DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

Job DescriptionJob DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

Exergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.Our Temporal Scanner™ is the most efficacious, non-invasive...

JOB DESCRIPTION: Quality System Specialist The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. Position details: Assist in governance of Quality System...

Internal Title: Quality Systems Specialist For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. Duration: 8-month contract Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs) Responsibilities: Assist in the governance of Quality System applications, including harmonization of processes...

Job Description Responsible for developing, coordinating, implementing and auditing environmental, health and safety (EHS) programs that meet internal requirements as well as compliance with government regulations and/or industry consensus requirements. Maintains knowledge of current industry and regulatory EHS trends and provides subject matter expertise...

Pay Range: $35.47 - $41.12 The base pay range is a good faith representation of current potential base pay for successful applicants. Shift differentials have been included in the range. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity and contracts. * Assumes responsibility for the establishment,...

Are you ready to take our leading Oncology pipeline to the next level? As an Associate Director (AD) Study Leader Cell Therapy, you will be responsible for delivering a single or several smaller Cell Therapy development programs. This role requires a high degree of flexibility and autonomy, as you may also provide expert input to other non-drug programs and...

is seeking a Senior Medical Director for a clinical-stage biopharmaceutical company. The successful candidate will be responsible for leading the clinical study protocol development process, reviewing and interpreting study results, and providing medical monitoring for active studies. This role is pivotal in extending and improving the lives of patients with...

Yardi is a global software company providing innovative property management solutions and services in every real estate market. We are focused on providing our customers with superior products and outstanding customer service. We are passionate about technology and believe work should be fulfilling and fun! We are committed to our customers, employees and...

Firefly Health is building a revolutionary new type of comprehensive health "care and coverage,” powered by a relationship-driven care team, a trusted virtual and in-person clinical network, and our proprietary technology platform.Founded by experienced clinicians and technology leaders, Firefly Health is on a mission to deliver clinical and financial...