Regulatory Submissions Specialist — FDA/eCTD Expert
Artech Information Systems LLC
A leading IT staffing company is seeking a skilled professional to join their Regulatory Affairs Operations team. The candidate will be responsible for publishing and maintaining regulatory filings while ensuring compliance with all necessary standards. Ideal candidates will have at least four years of submission publishing experience and a relevant bachelor's degree. This role offers a challenging environment with tight deadlines and responsibilities in a highly regulated field. #J-18808-Ljbffr Artech Information System LLC
- ...cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to... ...and health authorities.• Expert in publishing capabilities... ...component locations within the eCTD backbone structure.•... ...submissions through the FDA Gateway• Ensure adherence...SuggestedImmediate start
- ...Description Job Description Job Title: Regulatory Affairs Specialist Location: Remote Job Type:... ...documentation. Assess regulatory submissions and responses for accuracy and... ...adherence to ICH guidelines and CTD/eCTD requirements. Identify regulatory...SuggestedContract workRemote work
$101.44k - $126.8k
...About the Job: The Senior Specialist, Regulatory Affairs (CDx) performs... ...to support the regulatory submissions process through development... ...health authorities such as FDA for approval of novel platforms... ...with other subject matter experts as needed. Review and...SuggestedFull timeWork experience placementWork at office- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with cross...SuggestedFull time
$132.3k - $245.7k
...action.Job DescriptionKey Responibilities:Act as an internal expert in molecular and clinical imaging, including PET, SPECT... ...Therapy (RLT/RPT) is a plus. Experience in regulatory interactions, submissions, first-in-human imaging studies, endpoint validation or...SuggestedFull time$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist... ...coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$120k - $160k
...understanding of their bodies and daily lives.WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health... ...II, Expansion, you will support global regulatory submissions for global market access activities for Software as a...Full timeWork at officeRelocation$178.5k - $257.83k
...pharmacology and toxicology studies, authoring regulatory documents, being a member of an... ...global nonclinical safety issues on various expert groups or internal committees as... ...in preparing and submitting IND and CTD submissions.Minimum preferred skills:Experience as a...Full timeContract work$138.4k - $207.6k
...and Technology (AS&T) Principal Scientist, Separation Method Expert, will be responsible for providing scientific and technical... ...ensure on-time deliverables to meet program commitments.Support regulatory submissions and responses to inquiries from health agencies for INDs and...Full timeContract workWork experience placementSummer workRemote workWorldwideFlexible hours2 days per week$174.4k - $261.6k
...real difference, there’s only one choice.Director, In vivo Expert, CVRI (Cardiovascular, Renal & Immunology) Bayer has an opening... ...for projects moving through internal review stage gates and regulatory submissions; Employing VACC (Visionary, Architect, Coach, Catalyst)...Contract workLocal area$74.4k - $111.6k
...Regulatory Affairs SpecialistCareers that change lives start here. Medtronic... ...care.As a Regulatory Affairs Specialist in the Access and Instruments... ...documentation for regulatory submissions, renewals, registrations, and... ...include:Experience with U.S. FDA and international regulatory...H1bWork at officeLocal areaImmediate startFlexible hours- ...experience in Pharma / Biopharma Regulatory compliance and... ...RSO, ensuring data alignment, submissions, approvals, and license compliance... ...functionally & independently.The RSO Specialist will work closely with the... ...the contribution of site experts. The RSO Specialist may...Permanent employmentLocal area
- ...Talent. Job Description This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation,... ...), labeling updates for marketed products, generation of FDA meeting requests and corresponding briefing materials, and other...
- ...with the US regulation. Plan and prepare submissions for US Class II devices, including... ...responding to questions and requests from the FDA.Determine and document change... ...and compiling documents for submission to regulatory authorities, as well as assisting in responding...Worldwide
- ...Regulatory Affairs SpecialistThis is a full-time on-site role for a Regulatory Affairs Specialist located in Torrance, CA. The Regulatory Affairs Specialist... ...compliance, requirements, submissions, and overall regulatory... ...environmentKnowledge of FDA regulations and...Full time
- ...0+ employees world-wide.As a Clinical Regulatory Specialist at Iterative Health, you will play an... ...compliance.Prepare and coordinate initial IRB submissions, amendments, continuing reviews,... ...Clinical Practice (GCP), applicable FDA regulations and guidance, IRB requirements...Temporary workWork at office2 days per week
- ...inconsistencies, or ambiguities in legal materials. Apply meticulous attention to detail to maintain exceptionally high standards in all submissions. Preferred Qualifications Active license to practice law in the United States with strong academic credentials. Current...For contractorsRemote work
$140k - $200k
...as our Principal Medical Writing Domain Expert for Veeva Falcon. This is a rare opportunity... ...drafting and help design the advanced regulatory authoring system of your dreams. You... ...results and scaling to broader regulatory submissions Define "What Good Looks Like": Establish...Work at officeLocal areaImmediate startWork from homeFlexible hours- ...Overview This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare... ...U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements,... ..., notification and approval information submission to regulatory authorities or authorized...Local areaRemote workFlexible hours
- BNY Mellon, in Boston, MA, seeks an Associate, Regulatory Reporting to join the Fund Reporting team. You will prepare and coordinate regulatory filings for funds and ensure timely submissions to regulators. The role requires 3+ years in regulatory/financial reporting for...
$106k - $130k
A biotech company is seeking a Regulatory Affairs Senior Associate in Boston. The role focuses on supporting regulatory activities for innovative... ..., 2+ years in the pharma/biotech field, and knowledge of FDA regulations. The position offers a salary range between $106,00...- CRISPR Therapeutics, Inc. in Boston, MA is hiring a Senior Specialist, Drug Safety to support ICSR processing and ensure high-quality... ...environment. You will manage data entry, QC the ICSRs, ensure timely submissions to regulators and partners, and develop training materials....
$200k - $246k
...Description Job Description Healthcare Regulatory Career Associate Attorney Direct... ...Career Associate Attorney to join the FDA & Healthcare Regulatory practice of a prestigious... ...filings and licensing-related submissions. Assist clients in maintaining state...Temporary workWork at officeFlexible hours$200k - $240k
...Associate Director, Regulatory Affairs Operations At Merida Biosciences... ...will focus on regulatory submission planning, execution, and... ..., and electronic submission (eCTD) processes. Partner with Regulatory... ...and requirements, including FDA, EMA, ICH guidelines, and...Work at officeLocal area- Company DescriptionWhy should you join us?We are a leading provider of enterprise work management software and a dynamic, fast growing company with great opportunities and an employee focused company culture.We are an equal opportunity employer and value diversity at our...
$178.5k - $257.83k
...jobAs Global Clinical Development Strategy Expert within our Global Clinical Development... ...R&D strategy, franchise strategy, and regulatory needs, and present for endorsement with... ...clinical trials (protocols, reports), CTD submissions, and interactions with governance bodies...Full timeTemporary workFlexible hours$152.6k - $283.4k
...a positive and inclusive work environment where we can solve the toughest healthcare challenges together.The Strategic Feasibility Expert is accountable for the clinical feasibility strategy for Biomedical Research (BR) therapeutic areas (TAs) and patient trials managed...Full timeShift work$126k - $234k
...Description SummaryWhat if your data science expertise could help shape safer medicines for millions of patients worldwide? As a Senior Expert I or Senior Expert II Data Science, you will apply advanced artificial intelligence, machine learning, and computational modelling...Full timeWorldwideRelocation package- ...inclusive experience for all users. As part of this initiative, the organization is seeking an experienced Accessibility Subject Matter Expert to lead accessibility assessments, remediation efforts, compliance guidance, and training across multiple business units.This role...Hourly payFull timeContract workWork at officeMonday to Friday
$100k - $275k
...guidance and is focused on achieving the strategic objectives of the organization while balancing risk and regulatory compliance. This functional Subject Matter Expert negotiates, manages, and mentors others on highly complex and strategically important cradle-to-grave...Full timeContract workFor contractorsFor subcontractorWork at officeLocal area
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