Regulatory Submissions Lead (Remote EST)
GForce Life Sciences
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
- ...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...Remote workRegulatory
- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...match, stock incentives, and generous PTO. This position offers a remote work option with travel as needed. #J-18808-Ljbffr...Remote workRegulatory
$221k - $286k
...Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide global... ...includes overseeing global CMC strategies, submissions, and managing workforce talent.... ...benefits. This position offers flexible work with remote options. #J-18808-Ljbffr Kite PharmaRemote workRegulatoryFlexible hours- ...biotechnology company is seeking a Senior Specialist for Regulatory Operations to manage regulatory submissions and support systems in Frederick, MD. This role... ...submission standards. Responsibilities include leading submissions, working with vendors, and overseeing document...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 workRegulatoryFlexible hours
$130k - $160k
A leading diagnostics firm is seeking a Manager, Medical Writing, responsible... ...writing team and ensuring high-quality regulatory documents for market submissions. The role includes mentoring... ...pharmaceutical sector. The position is fully remote, offering a compensation range of $...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$130.8k - $209.4k
...alignment with program goals, regulatory expectations, and business... ...stability sections for regulatory submissions, responses, and technical... ...and expiry‑related planning. Lead or support investigations for... ...presence at the Moderna site. Remote work is not eligible. Preferred...Remote workRegulatoryPermanent employmentFull time- ...Talent is seeking a highly skilled Pharma Submissions Specialist to manage the submission... ...products. You will ensure compliance with regulatory requirements and timely submissions to health... ...This temporary position offers flexible remote work within the US and is ideal for...Remote workRegulatoryTemporary workFlexible hoursAfternoon shift
- A leading clinical research organization is seeking a Nonclinical Writer to develop and write regulatory documents. The role involves collaborating with cross-functional teams and ensuring... ...with GLP and ICH guidelines are essential for this remote position. #J-18808-LjbffrRemote workRegulatory
$130k - $150k
.... The candidate will be responsible for producing high-quality regulatory documents and collaborating with cross-functional teams to ensure... ...offers a salary range of $130,000 - $150,000 USD annually, remote work flexibility, and a comprehensive benefits package. #J-1880...Remote workRegulatory$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- ...is seeking a Senior Principal Scientist (Sr. Director level) in Regulatory Affairs CMC, focused on dry powder inhaler combination products... .... Benefits include a comprehensive package and a potential remote work option for qualified candidates. #J-18808-Ljbffr...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 workRegulatory
$176.4k - $207.5k
...Recursion is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and oversee processes. This role requires... ...ensure compliance with regulatory requirements. The position is remote-friendly, with a salary range of $176,400 - $207,500 (USD)...Remote workRegulatory$70 - $117 per hour
...Planet Pharma is seeking a Director of Regulatory Affairs to provide senior regulatory leadership... ...environment. This role involves leading global regulatory strategies for Phase... ...with the ability to manage regulatory submissions and stakeholder communications. Competitive...Remote workRegulatory- 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 workRegulatoryPart time10 hours per week
- ...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
- ...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 workRegulatoryFull time
- ...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....Remote workRegulatory
- ...A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5–10 years of experience in Regulatory CMC, a strong technical background in relatorette...Remote workRegulatory
- ...A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology... ...project management skills. You will lead FDA submissions and interact with regulatory authorities to ensure...Remote workRegulatoryFull time
$142.8k - $196.35k
...USA SOLVENTUM US LLC is seeking a Principal Regulatory Affairs Specialist to lead regulatory submissions and strategy for the Dental Solutions business across global... ...expertise in product labeling compliance. This remote role may involve up to 10% travel. Compensation...Remote workRegulatory- A leading staffing agency is looking for a Study Lead Statistician to oversee statistical... ...functional teams for results that meet regulatory standards. The ideal candidate holds a... ...analysis, managing timelines, and supporting regulatory submissions. #J-18808-LjbffrRemote workRegulatory
$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- ...United Cerebral Palsy of Georgia is seeking a Regulatory Affairs Professional to lead regulatory strategies for medical devices in a fully remote position. The role requires over 8 years of experience in FDA submissions and regulatory compliance with a BA or BS degree....Remote workRegulatory
- ...biotechnology consulting firm is seeking a Regulatory Affairs Consultant to support... ...10-20 hours of work per week. This remote position requires expertise in regulatory... ...products. Responsibilities include leading regulatory submissions, engaging with the FDA, and...Remote workRegulatory10 hours per week
- ...Solventum seeks a Principal Regulatory Affairs Specialist to lead regulatory strategy and submissions for its Dental Solutions business. This remote role requires extensive experience in regulatory affairs within the drug and medical device industry, supporting global...Remote workRegulatory
- ...Syneos Health, Inc. is seeking a Principal Medical Writer to lead the development of regulatory documents for submissions to authorities globally. The role involves oversight of multiple projects and mentoring junior writers, ensuring documents are scientifically sound...Remote workRegulatory
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