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...

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...

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...

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...

**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 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...

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...

The Assistant Vice President (AVP) will be responsible for asset-related, Bermuda regulatory capital reporting for our multiple reinsurers, coordinating accounting, and investment support in a larger matrix organization. The Assistant Vice President will evaluate new investments for capital impact, represent us in development of new reporting, controls, and...

Job DescriptionJob DescriptionPrincipal Regulatory Affairs SpecialistJob DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class III...

Job Description Job Description Principal Regulatory Affairs Specialist Job DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class...

Responsibilities: Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineering, Law, Customer Energy Solutions, Corporate Accounting and IT, and other...

Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC,...