Regulatory Submissions Delivery Lead
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 for publishing staff while managing operational activities. This role includes coordinating publishing deliverables, ensuring quality standards are met, and overseeing the content delivery process throughout the product lifecycle. Strong organizational skills are essential for handling competing priorities. #J-18808-Ljbffr 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...Regulatory
- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...Regulatory
- Monte Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston, MA. This role... ...regulatory operations with proficiency in eCTD submissions and vendor oversight. The candidate will... .... The position offers an opportunity to lead cross-functional teams and contribute to...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
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing... ...products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA...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
Ipsen Biopharmaceuticals Inc. is seeking a Document Specialist to support regulatory submissions by ensuring documents are high-quality and ready for submission. The role requires collaboration with teams and experience in document management within the pharmaceutical...Regulatory- Ketryx is seeking a Delivery and Success Manager in Boston, MA to enhance strategic client engagement for MedTech enterprises. This role... ...onboarding to partnership success while collaborating with regulatory experts to drive measurable outcomes. Ideal candidates have 5-...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
- Cognizant in Boston, MA is seeking a professional to lead end-to-end delivery of Manufacturing Execution Systems (MES) projects, including management... ...to ensure system reliability and compliance with regulatory standards. The ideal candidate should have experience in project...Regulatory
- AVEO Oncology is seeking an Executive Director for Regulatory Operations. This role involves providing strategic leadership for global regulatory operations, ensuring compliance and submission quality across the product lifecycle. The successful candidate will establish...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
- Key Responsibilities Lead end-to-end delivery of lab automation and workflow orchestration initiatives to drive scalable, efficient lab and logistics... ...by ensuring solutions meet architectural, security, and regulatory requirements and align with enterprise platforms and data...Regulatory
$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- Executive Director, Regulatory Operations and Submission Management The Executive Director, Regulatory Operations will provide strategic and operational... ...and lifecycle. This role is accountable to build and lead a high-performing Regulatory Operations function and for...Regulatory
- ...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 field and 3-5 years...Regulatory
- Katalyst 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
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development... ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory- 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
$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
- ...seeking an experienced Head of Medical Writing to lead the development and delivery of high-quality clinical and regulatory documents. This role involves providing... ...strong background in clinical development and regulatory submissions. #J-18808-Ljbffr RBW Consulting LLPRegulatory
- Mass Digital Health is seeking a Global Submission Lead in Cambridge, MA, or Morristown, NJ.... ...planning, coordination, and execution of regulatory submission activities within the R&D team... ...and external partners to ensure timely delivery of high-quality submissions, supporting...Regulatory
$210k - $255k
...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 team members, contributing...Regulatory- ...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
- ...seeking a Principal Statistical Programmer to lead clinical programming efforts. This role... ...teams, ensuring compliance with regulatory standards, and managing team tasks effectively... ...communication skills and regulatory submission expertise are essential for success in this...Regulatory
- Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This senior role requires a candidate with strategic leadership skills and over 10 years of regulatory experience in the pharmaceutical...RegulatoryLocal area
- ...Regulatory Associate (CMC) Submission Management and Publishing Support 6 month contract Must be able to work on a W2 Hybrid 3x per week in Waltham, MA Requirements Support the planning, coordination, and execution of regulatory submissions, including INDs...RegulatoryContract workWork at office
- Xenon Pharmaceuticals Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA office. This role involves supporting global regulatory submissions through effective collaboration with cross-functional teams. Ideal candidates will have over...RegulatoryWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Submissions Delivery Lead. Be the first to apply!
- regulatory executive Cambridge, MA
- regulatory accountant Cambridge, MA
- regulatory scientist Cambridge, MA
- regulatory contract Cambridge, MA
- regulatory law Cambridge, MA
- food regulatory Cambridge, MA
- regulatory technician Cambridge, MA
- regulatory engineer Cambridge, MA
- regulatory Cambridge, MA
- delivery ambassador Cambridge, MA

