Regulatory Submissions Lead (Remote EST)
GForce Life Sciences
- Remote job
A leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves vendor oversight, quality control of submission-related documents, and ensuring compliance with submission standards and regulations. Candidates should have 3-5 years of regulatory operations experience, particularly in the US and Europe. This is a remote position requiring expertise in compliance and submission guidelines. #J-18808-Ljbffr GForce Life Sciences
- ...Scorpion Therapeutics is looking for a Senior Specialist in Regulatory Operations to oversee submission management across the development pipeline and support the commercial portfolio. This role requires experience in regulatory operations in the biotech/pharma sectors...Remote workRegulatory
- Women In Bio seeks a Regulatory Affairs Specialist to lead the planning and delivery of regulatory submission dossiers in the United States. You will collaborate with teams across... ...allows for both in-office teamwork and remote focused work days. #J-18808-Ljbffr Women In...Remote workRegulatoryWork at office
- GSK is looking for a professional in regulatory affairs to lead the planning and delivery of regulatory submission dossiers. The role involves collaboration with various... ...for both in-office collaboration and focused remote work. Candidates should have at least 3 years...Remote workRegulatoryWork at office
- Alfasigma is seeking a Manager, Regulatory Lead to support regulatory strategy development and IND submissions in a fast-paced environment based in Boston. This role involves collaboration and project management across various functions. Ideal candidates will have a Bachelor...Remote jobRegulatory
- ...Associate Director, Medical Writing to oversee regulatory submissions and manage related documentation. This... ...preferred. The Associate Director will lead a team of medical writers, ensuring... ...and project management abilities. Remote work is available, but face-to-face interactions...Remote jobRegulatory
$70k - $130k
...company is seeking a Senior Specialist in Regulatory Operations to manage regulatory submissions across their development pipeline. The role involves leading submission management and ensuring... ...field. The position can be remote or based at the company's office in...Remote jobRegulatoryWork at office$70k - $130k
Tonix Pharmaceuticals is seeking a Senior Specialist, Regulatory Operations to manage submission processes across the development pipeline. This role requires... ..., dental, and retirement options. Flexibility to work remotely is also available. #J-18808-Ljbffr Tonix...Remote jobRegulatory- A leading healthcare intelligence firm is seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will have an advanced degree... ..., particularly in regulatory submissions. This role offers a competitive salary...Remote jobRegulatoryFlexible hours
- ...transform people’s lives. Position Summary You will lead the planning, compilation, and delivery of regulatory submission dossiers for investigational and lifecycle... ...States, combining in‑office collaboration days with remote work as agreed with your manager. Benefits...Remote workRegulatoryWork at officeLocal area
- A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development...Remote jobRegulatory
- BridgeBio Pharma in California is seeking a Regulatory CMC professional to lead the regulatory strategy for IND, NDA, and MAA submissions. The role requires extensive experience in... ...allows for a hybrid work model, combining remote work with periodic office visits in San...Remote jobRegulatoryWork at office
- Creative Solutions Services, LLC is seeking a Remote Senior Medical Writer to join their Regulatory Operations team. The role involves preparing clinical regulatory documents and managing multiple projects while ensuring compliance with guidelines. The ideal candidate will...Remote jobRegulatory
$130k - $150k
...writing experience in a Sponsor or CRO setting, along with a Bachelor’s degree in a scientific discipline. Responsibilities include leading the preparation of clinical trial documents and collaborating with various teams. Competitive salary between $130,000 and $150,000...Remote jobRegulatoryFlexible hours$115k
...Hybrid — 50% in-office / 50% remote) Experience: 3+ Years... ...datasets for evidence generation, regulatory submissions, and market access. We are... ...Demonstrated ability to qualify leads rigorously before pushing it... ...Preference for NYC-based; EST or CST timezone required...Remote workRegulatoryWork at officeFlexible hours- 6AM City, LLC is seeking a Regulatory Operations Contractor to support the development... ...of systems for regulatory submission activities. This position offers fully remote work options and requires candidates to work during EST hours. Responsibilities include assisting...Remote workRegulatoryContract workFor contractors
- ...A leading healthcare company is seeking a Manager of Regulatory Affairs based in remote locations. You will develop and execute regulatory strategies, manage FDA submissions, and ensure compliance for innovative medical devices. The ideal candidate has over 8 years of...Remote workRegulatoryFull time
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workRegulatory- ...POSITION OVERVIEW As a Global Regulatory Affairs Leadyour roles and responsibilities... ...Regulatory Affairs Manager to lead regulatory strategy, submissions, and compliance activities for... ...Location: Covington, Georgia Remote / Hybrid: On-site (4 days per week...Remote workRegulatoryPermanent employmentFull timeFor contractorsRelocation
- ...Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory... ...guidelines, with a proven record of successful submissions. This position promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr CRISPR TherapeuticsRemote workRegulatoryFlexible hours
- ...Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory... ...and marketing applications. The role is remote and emphasizes collaboration with... ...experience and strong expertise in regulatory submissions. Competitive salary and comprehensive...Remote jobRegulatory
$176.4k - $207.5k
Recursion is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and oversee processes. This role requires at... ...compliance with regulatory requirements. The position is remote-friendly, with a salary range of $176,400 - $207,500 (USD)...Remote workRegulatory- ...company in Somerville is looking for a Sr. Regulatory Affairs Principal. This role involves... ...for high risk FDA Class III products, leading submissions and ensuring compliance with global... ...offers the flexibility to work remotely and requires excellent communication and...Remote jobRegulatory
- Ceradis is seeking a Regulatory Country Manager for Central EU (DE-AT-CH) and CIS to manage submissions and compliance with regulations. The ideal candidate will have at least 5 years of experience and a background in chemistry, biology, or agronomy. This role requires...Remote jobRegulatory
- ...Compliance – Export Controls Lead based in the United States. This... .... This position combines regulatory expertise with strategic business... .... It is a fully remote role offering high visibility... ...export classification, licensing submissions, and management of controlled...Remote workRegulatoryPermanent employmentWork from home
- Biocartis is searching for a Senior Regulatory Affairs Specialist to develop regulatory strategies... ...with IVDR and global standards. This remote position requires a Bachelor's degree... ...-functional teams, preparing regulatory submissions, and monitoring changing market...Remote jobRegulatory
- ...Compliance Team LeadApplylocations: Remote - Connecticut: Remote -... ...is seeking a Compliance Team Lead to help scale and strengthen... ...compliance solutions* Track regulatory and framework updates to keep... ...value your time and take each submission seriously.)*Our teams are dedicated...Remote workRegulatory
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote jobRegulatory
- El Camino Health is looking for a regulatory affairs professional to develop and execute strategies... ...for medical devices. This full-time remote position requires 8-10 years of... ...including authorship of 510(k)s and FDA submissions. The ideal candidate will demonstrate strong...Remote jobRegulatoryFull time
- Inside Higher Ed is seeking a Regulatory Compliance Officer - Clinical Trials Office to assure... ...documents, informed consent forms, and submission packets. This position requires a... ...processes is essential. The role is primarily remote but involves communication with several...Remote jobRegulatoryWork at office
- A leading regulatory consulting firm is seeking a Regulatory Affairs Consultant to support ongoing projects in Raleigh, NC. This remote role involves developing regulatory strategies, leading regulatory submissions, and interacting with the FDA. An advanced degree in science...Remote jobRegulatoryPart time10 hours per week
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