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
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Regulatory Submissions Specialist — FDA/eCTD Expert in Cambridge, MA vacancy
$160k - $240k
...Pharmaceuticals Inc. is seeking an Associate Director of Regulatory Operations to oversee regulatory submissions and compliance. This role requires a Bachelor’s... ...Regulatory Affairs Operations, and a strong understanding of FDA regulations. The position operates in a hybrid model...Suggested- ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...documents, and ensuring compliance with FDA regulations. Candidates should have a...SuggestedWork at office
- ...biopharmaceutical organization seeks an experienced eCTD Publishing Manager for a contract role... ...qualified candidate will work on eCTD submissions and data migration, requiring advanced... ...the opportunity to significantly impact regulatory compliance processes. #J-18808-Ljbffr...SuggestedHourly payContract work
$91.5k - $134.2k
Ipsen Innovation (SAS) seeks a Document Specialist in Cambridge, MA, to support Regulatory and submission teams in electronic regulatory submissions globally. The role involves ensuring documents are completed to high standards and mentoring authors on compliance with standard...Suggested- ...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
Artech Information System LLC
Cambridge, MA23 hours ago - CeDent is seeking a Regulatory Affairs Specialist for an on-site role in Boston, MA. The successful candidate... ..., ensure compliance, and support all submissions and regulatory affairs activities.... ...with regulatory agencies such as FDA/DEA and Boards of Pharmacies, maintaining...
- Parexel in Boston seeks a Regulatory Affairs Consultant/Senior Consultant to lead regulatory efforts for a major pharmaceutical client.... ...management. The role emphasizes health authority interactions, submission planning, and compliance oversight while coordinating with...
$69.77k - $93.04k
Overview Compliance Specialist III - The TPA Experts at NBT Bank Pay Range: $69,765.00 - $93,042.00 The Compliance Specialist III is directly responsible... ...publish Form 5500, Form 5330, Form 8955-SSA and other regulatory forms required. Reconcile and prepare the Form 5500 and...Full timeTemporary workWork visaFlexible hours- ...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...
Makro Scientific
Cambridge, MA1 day ago - ...Job Title Manage line of FDA regulated products: Consumer medical devices (hot/cold... ...information, timely. Interpret regulatory rules or rule changes and ensure that such... ...Experience Certified Customs Classification Specialist (CCS), helpful. Exceptional written,...
MRINetwork
Boston, MA3 days ago $94k - $150k
...Senior Regulatory Affairs Specialist The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory... ...include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA,...Full timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
Cambridge, MA23 hours ago- ...This is a full-time on-site role for a Regulatory Affairs Specialist located in Torrance, CA. The... ...documentation, compliance, requirements, submissions, and overall regulatory affairs activities... ...a team environment Knowledge of FDA regulations and guidelines Knowledge...Full time
CEDENT
Boston, MA2 days ago - CeDent is seeking a detail-oriented Regulatory Associate to join its Regulatory Affairs team in Boston, MA. This role involves preparing and submitting regulatory documents, ensuring compliance with relevant standards, and facilitating clinical trial and product approvals...
- 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...$90k - $125k
...Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team... ...for preparing and managing submissions to the FDA and select international regulatory... ...with electronic submission standards (eCTD) and regulatory publishing tools...Full timeImmediate startFlexible hoursCareerscape
Boston, MA28 days ago- ...Investigation Plans, Scientific Advice, and other regulatory documents; review internal and external... ...for global nonclinical safety issues on expert groups or committees; prepare scientific... ...preparing and submitting IND and CTD submissions. Minimum Preferred Skills Experience...
- ...the Head of PV Ops, the Senior Specialist, Drug Safety will support individual... ...CRISPR programs Ensure timely submission and compliance of assigned ICSRs to global regulatory authorities, business partners,... ...PV vendor(s) Knowledge of FDA, ICH, EU regulations and requirements...Remote 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...Contract workWork experience placementSummer workRemote workWorldwideFlexible hours2 days per week$32.69 - $33.65 per hour
Bay Cove Human Services in Boston is seeking a Revenue Cycle Posting Specialist to help manage electronic claims submissions and ensure compliance with payment standards. The role requires strong understanding of accounting principles and experience in payment posting and...Hourly pay$150k - $200k
...seeks a Validation SME with a focus on business development in Boston. You will manage projects, lead a team, and ensure compliance with FDA regulations. The ideal candidate will have over 15 years of experience in GMP environments and a proven ability to drive customer...$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...Contract workWork experience placement$71k - $112k
Job Title Regulatory Affairs Specialist I Job Description The Regulatory Affairs Specialist I supports regulatory... ...device regulations, including FDA regulations, EU MDR requirements, and... ...products. Assist with regulatory submissions, registrations, renewals, and product...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- Regulatory Specialist - Clinical Research Coordinator Core Join to apply for the... .... Prepare and assist in submission of protocol amendments, IND... ...submitting IND applications to the FDA. Preparation and submission... ...knowledge in a new way. Experts add insights directly into each...Full timeWork experience placementWork at officeLocal areaImmediate startRemote workShift work
$40.4k - $67.4k
...below, About the Role The Compliance Specialist II is responsible for submitting notice... ...changes from client and preparation and submission of all files and related documents to state... ..., understanding and appreciation of regulatory functions and issues. Actively develops...Permanent employmentWork at officeLocal areaDormont Manufacturing Company
Medford, MA3 days ago- ...requirements. Escalate any potential reporting requirements. Assist with preparing global shareholder ownership filings for submission to applicable regulatory authorities as needed. Assist in the implementation and maintenance of the compliance system to monitor client...Work at officeRemote workMonday to FridayFlexible hoursDay shift
Geode Capital Management
Boston, MA4 days ago $100 per hour
...edge AI projects with leading LLM companies. Pay rate: $100+/hour (depends on role and candidate expertise). Assessment: Shortlisted experts complete an evaluation before selection. Assignments: Contract roles with defined start/end dates; up to 40 hrs/week. #J-18808-...Contract workRemote workFlexible hoursTuring
Boston, MA1 day ago- ...Job description Final rate depends on location, qualifications and experience We are seeking a Mechanical Engineering expert with advanced CAD and Computational Fluid Dynamics (CFD) experience to support a leading AI lab developing next-generation engineering AI models...Part timeImmediate startFlexible hours
Braintrust
East Boston, MA7 hours ago $65k - $150k
...Veeva Clinical Database (CDB), working with our customers focused on North America. As part of the Clinical Data Management Product Expert team, you will play a key role in the Product organization. Most importantly you will: Represent the Product organization and be an...Work at officeLocal areaRemote workWork from homeFlexible hoursVeeva Systems
Boston, MA5 days ago$60 per hour
A leading AI development company is seeking experienced quantitative professionals to work remotely. Candidates will evaluate AI-generated quantitative work and design problems for AI training. This position requires 2+ years of experience in a quantitative field and coding...Hourly payRemote workFlexible hoursDataAnnotation
Boston, MA1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Submissions Specialist — FDA/eCTD Expert. Be the first to apply!
Related searches
- regulatory compliance specialist Cambridge, MA
- regulatory affairs consultant Cambridge, MA
- regulatory affairs specialist Cambridge, MA
- compliance coordinator Cambridge, MA
- cybersecurity policy and compliance analyst Cambridge, MA
- compliance specialist Cambridge, MA
- healthcare compliance officer Cambridge, MA
- coding compliance specialist Cambridge, MA
- regulatory specialist Cambridge, MA
- risk and compliance analyst Cambridge, MA