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
$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- ...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$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- ...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
- 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
$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- ...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
- ...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
$177k - $278.08k
...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...regulatory strategy and lead major submissions for high-impact oncology programs.How you... ..."hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workRegulatoryMinimum wageTemporary workLocal areaWorldwide$91.4k - $125.6k
...thinking Data Center Sustainability Lead to support large, hyperscale... ...with client ESG goals and regulatory requirementsManage and... ...credit tracking, audits, and submission processesCollaborate with design... ...Jacobs offices/projects and remote locations enabling them to deliver...Remote workRegulatoryFull timeFor subcontractorWork at office- ...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
- iRhythm Technologies, Inc. is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for wearable medical devices and SaMD. You will drive submissions, interact with authorities, and guide cross-functional teams through lifecycle changes. The...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
- 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
- ...Location with ZIP: 1500 Post Oak Blvd, Houston, TX, 77056Is remote work an option?: NoIf remote work, please indicate... ...team in internal and external audits. Work with regulatory team on regulatory document submission.Bachelor’s or master’s degree in Information Management...Remote workRegulatoryHourly payPermanent employmentFor contractorsWork at officeAfternoon shift
$192.4k - $302.39k
...Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal... ...vendor(s) to ensure timely submission and approvalActively track, enter... ...with Takeda’s Hybrid and Remote Work policy.Empowering Our People...Remote workRegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal area- ...the real world.The Portfolio Integration Lead (PIL) is a senior role in Oncology... ...global health authority interactions, regulatory submissions and key development milestones across multiple... ...model, with a mix of on-site and remote work. Remote or fully home-working arrangements...Remote workRegulatoryFull timeLocal areaWork from homeRelocation
$135.23k - $150.25k
...TeamEversource is looking for a Lead Project Controls, Planning &... ...EOC and COC vendor schedule submissions are processed timely, with... ...corporate procedures consistent with regulatory requirements. Performs... ...apply to roles approved for remote work and are subject to change...Remote workRegulatoryFull timeContract workFor contractorsH1bWork at office$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- ...in the United States is seeking a Senior Regulatory Affairs Product Associate for the... ...implantable medical devices, manage global submissions, and partner with cross-functional teams throughout the product lifecycle. This remote role requires at least Bachelor's degree...Remote jobRegulatory
$169.5k - $248.6k
...to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...managementUS FDA OversightOversee all US FDA submissions and agency interactions, including INDs... ..., IN and relocation is provided, remote is not available for this role.Additional...Remote workRegulatoryLocal areaRelocationFlexible hours- ...America (SMPA) seeks a Senior Manager, Regulatory Affairs CMC (Oncology) to join the... ...focuses on regional CMC regulatory lead, coordinating submissions and responses to Health Authority requests... ...cross-functional teams. Primarily remote with periodic on-site meetings, and...Remote jobRegulatory
- ...AG is seeking a Sr Scientist - Global Regulatory Project Lead in Indianapolis, IN. This role... ...guiding regulatory strategy and leading submissions for farm and companion animal products... ...position offers flexibility with hybrid and remote options along with a comprehensive...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 jobRegulatoryFull time
- ...Pharma is seeking a Global Statistical Lead for Solid Tumor Oncology in Northbrook,... ...analytics for oncology clinical trials and regulatory submissions, as well as mentoring team members and... ...in statistical methodologies, offers remote work flexibility, and values work-life...Remote workRegulatory
- ...healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville,... ...FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s... ...communication skills. This position is remote and requires some travel. Competitive...Remote jobRegulatory
$144.06k - $205.8k
...global leadership role in the Regulatory Affairs department for the... ...of regulatory documents and submissions. Responsible for multiple regulatory... ...:Acts as a CMC regulatory lead for highly complex projects/... ...is based in Westborough, MA. Remote work from anywhere in the US...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- ...Clinical Trials Inc. is seeking an experienced Study Start-Up Lead to join our global team. You will oversee all start-up... ...requires 5+ years in clinical research, with 2+ years in SSU or regulatory submissions (CTIS), strong regulatory knowledge, and proven budget and contract...Remote jobRegulatoryContract work
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