Senior Regulatory Documentation Specialist - eCTD & Veeva
Avetix Bio
Avetix Bio is seeking a Specialist III, Regulatory Documentation to lead and guide the management and publishing of regulatory documents ensuring conformance with Health Authority requirements. The role supports staff in document management and coordinates eCTD modules. The ideal candidate has a Bachelor’s degree in life sciences or technical discipline and 5+ years of regulatory operations experience, with expert knowledge of Health Authority procedures and Veeva Vault (RIM). #J-18808-Ljbffr Avetix Bio
$45.66 per hour
...disease. Position Summary The Specialist II, Regulatory Documentation reports to the Director, Regulatory... ...of Electronic Common Tech Document (eCTD) modules. Essential Functions... ...Management Systems Working knowledge of Veeva Vault especially Veeva RIM...SuggestedHourly payTemporary workMonday to FridayFlexible hours- ...Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate...SeniorFlexible hours
- ...Pharmaceutical, Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance. You will also manage document workflows and corporate records, enabling timely...Suggested
- ...Senior Regulatory Affairs SpecialistOrganOx is a commercial stage organ technology company... ...regions.The Senior Regulatory Affairs Specialist is responsible for leading and supporting... ...requirements, review supporting documentation, and help ensure development and change...Senior
$115k - $135k
...around the world. Responsibilities Publishes US Regulatory Submissions to the Food and Drug... ...Reports, PADERS, etc. on time in accordance with eCTD submission requirements. Works with the Manager as well as document authors or leads across all disciplines to develop...SeniorWork at officeFlexible hours- OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate with multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs...SeniorRemote job
- ...hospital operations, and life sciences in more than 160 countries and regions. Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. Q-Submissions, INDs, IDEs and PMAs) for North America as...SeniorFor subcontractorRemote workFlexible hours
- The Specialist III, Regulatory Documentation will report to the Director, Regulatory Documentation and will provide... ...of Electronic Common Tech Document (eCTD) modules. Essential Functions... ...project folders for projects Maintain Veeva RIM by uploading all submission, Health...
$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory... ...ensure timely delivery of submission documentation. Review and approve change... ...with regulatory systems (e.g., Veeva Vault, eCTD, etc.). Competencies In‑depth...SeniorFull timeWork at officeLocal area- ...world. About the Role The Regulatory Affairs Senior Associate is responsible for managing... ...FDA requirements. Author relevant eCTD sections using company templates and... ...FDA expectations for device related documentation. Prepare formal meeting packages and...Senior
$72k - $141k
...their fullest potential. The Compliance Senior Consultant is a strategic individual... ...advancing key compliance programs, enhancing regulatory responsiveness, and facilitating... ...assessment and remediation efforts, including documentation gathering, findings analysis, and...SeniorFull timeWork experience placementWork at office- ...assurance services. Our team is seeking a Contract Compliance Senior Consultant with experience performing royalty audits, franchise... ...accordance with the contract obligationsPrepare a written report with a documented explanation of the process, franchisees and licensees’ response...SeniorFull timeContract workWork at officeLocal area
$110.7k - $218.3k
Position Summary Senior Consultant - Regulatory & Compliance - Enterprise Operations & Risk Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen...SeniorLocal areaVisa sponsorship- Valcor Engineering Corporation in Springfield, NJ seeks a Quality Specialist to compile and maintain quality documentation, ensuring compliance with customer and regulatory requirements. You will coordinate cross-functional teams to ensure accurate data packages and on...
$90k - $200k
...Senior Manager, Financial Investigations Kroll's North American Investigations, Diligence... ...investigations, forensic accounting, regulatory compliance, including business... ...involved in an investigation Conduct and document testing of internal controls Write well...SeniorTemporary workFlexible hours- Withum is seeking a Contract Compliance Senior Consultant for its Risk Advisory practice. The role focuses on royalty audits, franchise compliance audits, revenue participation audits, lease reviews, vendor audits, and related contract-based projects. The Senior Consultant...SeniorContract workWork at office
- ...ANDA, NDA, IND and DMF for the U.S. FDA in eCTD format. Preparation, Review and filing... ..., prior to new product launch Manage regulatory correspondence mainly to CDER, FDA, User... ...CMC harmonization process of regulatory documentation at all manufacturing sites. Active participation...SeniorLocal area
- ...R10094604 Regulatory Specialist (Open) Location: Fairfield, NJ (Seppic) - Sales - North America... ...and provides the high-quality documentation customers rely on. SEPPIC INC. is seeking... ...customer quality complaints via VEEVA Vault, partnering with Sales and Customer...Worldwide
- ...Management and Compliance is all about thinking outside the box, challenging the status quo, and striving to be best-in-class. As a Senior Associate in Strategic Data Analytics within the Compliance, Conduct and Operational Risk (CCOR) organization, you will help lead...Senior
- Atlantic Health is seeking a Sponsored Projects Analyst III in Morristown, NJ to act as a strategic partner to the Government and Research Grants Manager. You will review and submit government and private grant proposals, ensure compliance, and guide project teams through...Senior
- Merck & Co. in Rahway, NJ is seeking a Senior Specialist, IT for the RDLM Product Team to support regulatory lifecycle and document management capabilities. You will analyze processes, manage requirements, and align technical capabilities with business needs in a regulated...Senior
$32.5 - $36 per hour
Job Description Overview\n Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States. This unique opportunity combines tax expertise...SeniorLocal area- ...Associate Principal Scientist, Regulatory Affairs Seeking R&D background experience along... ...notice. Software: Experience with Veeva Vault is nice to have Experience with... ...supporting CORA requests for dossiers and GMP documentation Maintain regulatory information in...Shift work
- ...Reference26-00449 Job Description: The Senior Manager in Statistics responsible for perform... ...activities in drug in-licensing, regulatory filings and marketing. Responsibilities... ...Review study report, manuscripts and other documents related to statistics. Work on responses...Senior
- ...and talented Individuals to join their firm.Job DescriptionOur senior accountant will develop an understanding of the companies engagement... ...personnel and perform analytical reviews of schedules and documents and will prepare supporting schedules as necessary. The senior...Senior
- Company DescriptionLeading Healthcare Company looking for a talented Senior Financial Analyst Job DescriptionThe Senior Financial Analyst is responsible for participating in value added financial analytics to facilitate top line growth and business efficiency in working...SeniorContract work
- ...and infrastructure. The role blends technical depth, pharma domain knowledge, and consulting maturity to operate independently at senior levels. Senior FDEs will scale engagements, mentor junior engineers, and contribute to reusable accelerators and reference architectures...Senior
- ...DLA Piper is seeking a talented Senior Attorney to join its Litigation group, Product Liability, Mass Torts & Class Actions subgroup. This position is on a non‑partnership track and is open to any US office, with a preference for candidates in the New York metropolitan...SeniorWork at office
- ...Storage Solutions seeks an experienced Senior Automation Solutions Expert to drive the automation business in North America, bridging the solutions engineering and sales teams to design and sell intralogistics projects. The role covers customer briefings, project drafts...SeniorContract work
- ...intercompany reconciliation process. Ensure intercompany balances are eliminated in consolidation. - Ensure intercompany loans are properly documented and accounted for, including the determination of short-term vs. long-term treatment. - Ensure intercompany profit is properly...SeniorTemporary workFlexible hoursShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Documentation Specialist - eCTD & Veeva. Be the first to apply!
- senior manager tax Summit, NJ
- senior implementation engineer Summit, NJ
- senior Summit, NJ
- senior manager legal Summit, NJ
- senior software engineer remote Summit, NJ
- senior designer remote Summit, NJ
- senior medical science liaison Summit, NJ
- senior level Summit, NJ
- senior performance tester Summit, NJ
- senior implementation project manager Summit, NJ



