Hybrid Regulatory Intern

The Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including: Assist in drafting, organizing, and editing regulatory documents for 510(k) submissions. Coordinate workflow for regulatory document reviews (internal and external) within submission timelines. Coordinate with...

Job DescriptionJob DescriptionThe Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including:Assist in drafting, organizing, and editing regulatory documents for510(k) submissions.Coordinate workflow for regulatory document reviews (internal andexternal) within submission...

Job Description The Director, Global Regulatory Lead, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.   Leads the Global Regulatory Product Team (GRPT).  Continually expands TA knowledge, and ensures strategic messaging and content of global...

About the JobThe Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...

Job Description About This Role  This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific antisense oligonucleotide...

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...

Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs. Major tasks and responsibilities include:Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory...

**Pay Range**: $169,400.00 - $266,200.00 **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169,400.00 - $266,200.00**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four...

**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join...

Scope of Position The various tasks performed by Atlantic Shores’ Engineering Team demand detail-oriented individuals with multi-faceted skills, particularly in-depth technical knowledge, flexibility, enthusiasm for individual and team tasks, and analytical problem-solving capabilities. As an Engineering Intern, an individual will work in a...

Job Description Oxfam America is seeking a highly organized marketing intern to work closely with its Brand and Engagement Team on outreach to target audiences, fulfilling requests, entering event information in data systems, and providing event organizing support to the public. This paid, full-time position will serve a key role in the operations of the...

Job DescriptionJob DescriptionGradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients by applying knowledge of US and international regulatory compliance for product stewardship. Responsibilities include providing regulatory interpretation and guidance, evaluating GHS hazards, reviewing safety data...

Job Description Gradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients by applying knowledge of US and international regulatory compliance for product stewardship. Responsibilities include providing regulatory interpretation and guidance, evaluating GHS hazards, reviewing safety data sheets (SDSs) and...

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the...

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the...

Duties and Responsibilities: Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing. Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports....

Duties and Responsibilities:Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and...

Duties and Responsibilities:Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

Job DescriptionJob DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is...