Regulatory Submission Delivery Manager
Careers Integrated Resources Inc
Regulatory Submission Delivery Manager Coordinate publishing deliverables in line with the strategic direction of programs/products. Act as the primary point of contact for publishing staff, managing daily workload and responsibilities. Serve as point of contact for various regulatory functions (e.g., CMC, Development, and Labelling) throughout the product lifecycle. Partner with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders. Ensure hand‑offs and deliverables from the authoring community are on time and meet submission standards and quality expectations. Primary point of contact for all operational activities, including allocation and tracking of publishing, formats, templates, and technical requirements. Oversee publishing deliverables daily to ensure successful execution of operational activities for assigned products. Coordinate and track delivery of required content with content owners for routine/maintenance submissions in all markets. Qualifications 8 years of regulatory submissions experience with expertise in eCTD submissions. Experience with Liquent tools is preferable. Ability to manage competing priorities and fast‑moving requirements. #J-18808-Ljbffr Careers Integrated Resources Inc
- Careers Integrated Resources Inc is seeking a Regulatory Submission Delivery Manager based in Cambridge, Massachusetts. The ideal candidate will have 8 years of experience in regulatory submissions, specifically eCTD submissions, and will act as the primary point of contact...Regulatory
- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...requirements. Key responsibilities include managing submissions to the FDA, providing regulatory...Regulatory
- Monte Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston, MA. This role demands over 5 years of experience in regulatory operations with proficiency in eCTD submissions and vendor oversight. The candidate will manage regulatory databases, maintain compliance...Regulatory
- AVEO Pharmaceuticals is seeking an Executive Director of Regulatory Operations to lead global submission management and ensure compliance and quality across submissions. The role requires extensive experience in regulatory operations and managing high-performance teams...Regulatory
- ...leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance...Regulatory
- Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams. The ideal candidate holds...Regulatory
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...RegulatoryFlexible hours$91.5k - $134.2k
...Biopharmaceuticals Inc. is seeking a Document Specialist to support regulatory submissions by ensuring documents are high-quality and ready for... ...collaboration with teams and experience in document management within the pharmaceutical environment. The ideal candidate...Regulatory- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...Regulatory
- ...Oncology is seeking an Executive Director for Regulatory Operations. This role involves providing... ...operations, ensuring compliance and submission quality across the product lifecycle.... ...successful candidate will establish processes, manage a high-performing team, and oversee the...Regulatory
- A biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory support, preparing technical documents, and ensuring compliance with FDA regulations...RegulatoryWork at office
$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...Regulatory$90k - $120k
Product Delivery Manager (Healthcare - Medicaid & Medicare) Join to apply for the Product Delivery Manager (Healthcare - Medicaid & Medicare... ...Medicaid, Medicare, and commercial payer operations. Regulatory Alignment: Ensure all solutions adhere to CMS, HIPAA, and state...RegulatoryFull timeRemote workFlexible hours- Ketryx is seeking a Delivery and Success Manager in Boston, MA to enhance strategic client engagement for MedTech enterprises. This role involves... ...to partnership success while collaborating with regulatory experts to drive measurable outcomes. Ideal candidates have...Regulatory
- ...is seeking a professional to lead end-to-end delivery of Manufacturing Execution Systems (MES) projects, including management of project scope, timeline, and quality. The... ...system reliability and compliance with regulatory standards. The ideal candidate should have experience...Regulatory
- Key Responsibilities Lead end-to-end delivery of lab automation and workflow orchestration... ...Research. Ensure delivery excellence by managing scope, timelines, and budget while... ...solutions meet architectural, security, and regulatory requirements and align with enterprise platforms...Regulatory
- Executive Director, Regulatory Operations and Submission Management The Executive Director, Regulatory Operations will provide strategic and operational leadership for global regulatory operations and systems, submission management and execution across the product portfolio...Regulatory
$90k - $115k
...the AI platform to power safe innovation. The Role As a Delivery and Success Manager at Ketryx, you will lead strategic client engagements, guiding... .... You’ll act as a trusted advisor, collaborating with regulatory and solutions experts to solve complex technical...RegulatoryH1bWork visa- ...trial analysis and decision-making. The successful candidate will apply biostatistical methods and manage analyst teams, with responsibilities in regulatory submissions and data integration. Preferred qualifications include an advanced degree in Biostatistics or a related...Regulatory
$80k - $95k
...#LifeatRealChem. Real Chemistry is looking for a Technical Delivery Manager to join our growing team! At ROOM42 (we are 21GRAMS’ in-house... ..., technical specifications, client approvals, and legal/regulatory reviews throughout the production lifecycle. Provide hands-...RegulatoryFull timeWork experience placementWork at officeLocal areaRemote work2 days per week- ...Healthcares & Life Sciences in Cambridge, Massachusetts is seeking an experienced individual to lead and manage publishing activities for various regulatory submissions including IND, NDA, and more. This role involves mentoring team members and ensuring adherence to...Regulatory
- ...looking to add to their team and are looking to hire a " Delivery Program Manager”. This role will be based out of Iselin, NJ/Boston, MA, and... ...and platform transformation, while ensuring alignment with regulatory, risk, and operational requirements. Primary...RegulatoryFull time
- Monte Rosa Therapeutics Inc. is looking for a Regulatory Operations Manager in Boston, MA. The selected candidate will manage eCTD submissions and oversee collaboration with external vendors to ensure timely submissions. This role demands expert knowledge in document management...Regulatory
$150k - $200k
...across drug development stages. The successful candidate will have over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge, Massachusetts. Responsibilities include leadership of writing...Regulatory$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...Regulatory- Creative Solutions Services, LLC in Cambridge, Massachusetts is seeking a Regulatory Submissions Lead to oversee publishing activities for IND, NDA, ANDA, and more. The ideal candidate will manage submission processes, ensure quality control, and mentor team members. A...Regulatory
$210k - $255k
...role requires expertise in clinical trial data and statistical programming. Ideal candidates will manage project teams, apply biostatistics methods for regulatory submissions, and communicate complex findings effectively. The position also supports mentorship of junior...Regulatory- Mass Digital Health is seeking a Global Submission Lead in Cambridge, MA, or Morristown,... ...planning, coordination, and execution of regulatory submission activities within the R&D... ...and external partners to ensure timely delivery of high-quality submissions, supporting...Regulatory
- ...Head of Medical Writing to lead the development and delivery of high-quality clinical and regulatory documents. This role involves providing scientific leadership... ..., and a strong background in clinical development and regulatory submissions. #J-18808-Ljbffr RBW Consulting LLPRegulatory
- ...materials. In this role, you will conduct editorial reviews, verify comments, and facilitate discussions among Medical, Legal, and Regulatory Advisors. Your expertise in English writing, alongside your ability to multitask and meet tight deadlines, will be essential in...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Submission Delivery Manager. Be the first to apply!
- sr. manager regulatory compliance Cambridge, MA
- senior regulatory manager Cambridge, MA
- director global regulatory affairs Cambridge, MA
- compliance director Cambridge, MA
- senior director regulatory affairs Cambridge, MA
- head compliance Cambridge, MA
- training and compliance manager Cambridge, MA
- regulatory cmc manager Cambridge, MA
- regulatory affairs manager pharmaceutical Cambridge, MA
- regulatory manager Cambridge, MA
