The Manager/Sr. Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices.
Primary Responsibilities:
Skills Must have experience with/be proficiency in the following:
Education Bachelor's degree in business administration, a life sciences discipline, information technology, etc.. A minimum of 5 years in Regulatory Operations or a related, relevant function.
Regulatory Publishing Manager I • Piscataway, NJ, United States
Regulatory Affairs Project Manager.Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries... Show more
With a passion for lifeJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally.At Getinge we exist to make life-saving technology acce... Show more
Supports North America Regulatory activitiesEnsure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project an... Show more
Regulatory Affairs Headquarters Principal Scientist.Department - Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease.Brief Description of Position-.The Regulatory Affairs H... Show more
Responsible for all regulatory affairs activities required to support lead, manage, review, and submit regulatory submissions to FDA including supplements, and post-approval reporting activities of... Show more
Job Description :The Senior Manager, Global Clinical Regulatory Lead, is responsible for providing strategic and operational direction for the planning, management, support and execution of regulat... Show more
Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, Promotion, and Labeling Lead will be responsible for managing regulatory strategy and material approva... Show more
The Fountain Group is currently seeking a CMC Regulatory Technical Writer II for a prominent client of ours.However, if local to Morristown area, will be expected hybrid.Details for the position ar... Show more
Advertising Compliance Reviewer.Independently reviews communications with the public submitted by firms for compliance with FINRA, SEC, MSRB and SIPC advertising rules and regulations.Assists with ... Show more
Regulatory Compliance SpecialistReady to make an impact in product compliance across the Americas? Join us as a Regulatory Compliance Specialist and ensure WD-40 Company's iconic products meet comp... Show more
Senior Specialist, Regulatory Affairs CMC.Education: Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).Experience: At least 4 years o... Show more
Director Regulatory Affairs Global Regulatory Lead (GRL II).The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementi... Show more
Director, US Regulatory Affairs.This individual will be responsible for providing strategic regulatory advice and oversight for all of Altimmune's US regulatory applications, including the preparat... Show more
Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions.Oversee submission-level and document-level... Show more
Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function.This role oversees Regulatory Affairs personnel and ensures effective execution of U.Ability ... Show more
A leading regulatory consultancy is seeking a CMC Regulatory Technical Writer II for a hybrid role in Morristown, NJ.The position involves authoring and managing regulatory dossiers while collabora... Show more
Principal, Regulatory Compliance.Blue Owl (NYSE: OWL) is a leading asset manager that is redefining alternatives.With over $315 billion in assets under management as of March 31, 2026, we invest ac... Show more
Director of Regulatory Affairs - North America.Location: Morristown, NJ, US, 07960.Overview: As Director of Regulatory Affairs - Cluster (North America), you are accountable for in-market regulator... Show more
Director, Regulatory Relations.Iselin, New Jersey, United States.CLS is the trusted party at the centre of the global FX ecosystem.Utilized by thousands of counterparties, CLS makes FX safer, smoot... Show more
Regulatory Operations/Affairs ManagerOnsite role New Brunswick, NJ Work Schedule:Mon - Fri, Business HoursThe External Manufacturing Quality Organization is seeking to recruit a Manager, Regulatory... Show more
