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
- Premier Research seeks a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team in a remote-capable role. You will drive regulatory strategy, manage CTIS submissions, and coordinate multi-region regulatory activities for biotech, medtech...Remote jobRegulatory
$150k - $195k
...for an Associate Director, Medical Writing, responsible for leading regulatory submissions and ensuring high-quality documentation. Applicants should... ...collaboration with cross-functional teams and entails remote work with some onsite presence in San Diego. #J-18808-Ljbffr...Remote workRegulatory- MMS is seeking a Regulatory Writing professional to join our remote team. The role focuses on development, writing, and management of highly... ..., including Module 2.4 and 2.6 eCTD submissions, IBs, and GLP data. You will lead projects, ensure regulatory alignment, and...Remote jobRegulatory
- ...Innovative Medicine is seeking a Manager, Regulatory Medical Writing to support across... ...-country postings and potential remote options. You will lead preparation of clinical documents, guide... ...ensure regulatory compliance across submissions. Strong leadership, writing, and...Remote workRegulatory
$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- ...Sr./Lead Media Buyer Company: IncubatorLab Location: Remote - Worldwide IncubatorLab is looking... ...understanding of ad compliance/regulatory guidelines on Meta and... ...between 9 AM and 1 PM EST) for high-level... ...third-party or agency submissions will be accepted....Remote workRegulatoryTemporary workWorldwide
$100 per hour
...contract termsAs a Workday Payroll Lead, you'll work in a team to... ...experienceKnowledge of payroll regulatory requirements (Tax,... ...yearsNeeds to be able to work EST hoursProactive communication with... ...strong delivery reputationFully remote flexibility and exposure to high...Remote workRegulatoryContract work$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- ...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 Jobleads-USRemote workRegulatoryFlexible hours
- ...Astellas is seeking a senior Regulatory Affairs professional based in Northbrook, IL, with global experience and a track record in NDA/IND strategies. You will lead submissions, interact with the FDA and health authorities, and guide cross‑functional teams through complex...Remote jobRegulatory
- VB Spine, a leading privately held spine company, is seeking a Sr. Staff Regulatory Affairs Specialist to drive global regulatory strategies for complex medical devices... ...development, lifecycle management, and submissions, ensuring compliant, timely product launches across...Remote jobRegulatory
- ...Academic Compliance to support location and program leaders in regulatory standards and strategic compliance initiatives. The role... ...programs, collaborate with stakeholders, and prepare regulatory submissions while maintaining knowledge of accreditation requirements. #J...Remote jobRegulatory
- ...Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across... ..., and lifecycle management, with responsibility for submissions (INDs, BLAs/NDAs, MAAs), Health Authority interactions, and...Remote jobRegulatory
- ...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
- Solventum, a new healthcare company, seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Dental Solutions portfolio across global markets, including the United States, Canada, and the EU. You will guide regulatory strategy, coordinate...Remote jobRegulatory
- ...motivated Clinical Trial Site Activation Lead to drive late-stage site activation globally. You will manage feasibility, regulatory submissions, and site readiness, coordinating... ...while ensuring compliance. In this hybrid/remote-friendly role, you will influence senior...Remote jobRegulatory
- Advita Ortho in the US (Remote) seeks a Sr Manager, Regulatory Affairs to provide strategic leadership for the postmarket regulatory team, directing regulatory strategies, submissions and ongoing compliance for commercialized orthopaedic products. You will collaborate with...Remote jobRegulatory
- Centene Corporation seeks a Quality Improvement professional to oversee the QA program, leading state HEDIS audits and regulatory submissions. You will support staff, coordinate with departments, and ensure compliance with government requirements and NCQA standards. Ideal...Remote jobRegulatory
- VB Spine, LLC is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for spinal... ...Authorities, guide post‑market submissions, and help ensure compliance across... ...QA, engineering, and manufacturing. Remote work options with travel are available...Remote jobRegulatory
- QuidelOrtho seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for new in‑vitro diagnostics... ...markets. You will manage U.S. submissions, interact with FDA and global... ...and CFR requirements. This role is remote eligible. The position requires leadership...Remote jobRegulatoryWorldwide
- Neurona Therapeutics is seeking a Senior Manager or Associate Director in Regulatory Affairs (CMC) to lead regulatory strategy for cell therapies and guide submissions. This remote-friendly role reports to the Head of Regulatory Affairs in a fast-growing CNS-focused company...Remote jobRegulatory
- ...Therapeutics in San Diego seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across... ...Analytical Development, and Regulatory Operations to drive submissions, health authority interactions, #J-18808-Ljbffr Travere...Remote jobRegulatory
$171.5k - $266k
...POSITION TITLEPolicy Solutions Regulatory LeadPOSITION LOCATIONRichmond,... ...*A Hybrid schedule of both Remote and In-Office days is required... ...core business hours of 9am-5pm EST.This position is available to... ...deadlinesAbility to think broadly and lead/influence without direct...Remote workRegulatoryFull timeWork at officeLocal area- Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions for marketed and development products. You will collaborate with cross-functional teams to ensure global regulatory requirements are met...Remote jobRegulatory
- 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
- ...DescriptionAs a Foreign Trade Zone Lead, you will be responsible for... ..., 19CFR, 15CFR, and other US regulatory agency requirements.... ...Compliance Manager and will be fully remote, working anywhere in the... ...deficiencies and corrective actions for submission to the Port Director.Oversee...Remote workRegulatoryFull timeWork experience placementVisa sponsorshipWork visaFlexible hours
$130k - $200k
A leading biotechnology company is seeking a Director of Regulatory Affairs for Infectious Diseases. This position is responsible... ...global regulatory strategies, submissions, and cross-functional... ...role offers the flexibility of remote work and requires interaction...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
- ...Corporation is seeking a senior Regulatory Affairs leader to develop and... ...and ANMAT to influence submissions and timelines, ensuring alignment... ...product goals. You will lead a regional regulatory team, mentor... ..., and Commercial teams. Remote home office with 15-25% travel...Remote jobRegulatoryHome office
- Jobtailor is seeking an experienced Regulatory Affairs professional in the United States to... ..., and marketing to prepare and file FDA submissions and ensure global health authority compliance... ...skills. Advanced degrees are a plus; remote work options may vary. #J-18808-Ljbffr...Remote workRegulatory
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