Senior Regulatory Publishing Lead — Global Submissions
Vertex Pharmaceuticals
Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions, coordinate with regulatory document authors and submission managers, and drive process improvements ensuring compliant, high-quality output across programs. #J-18808-Ljbffr Vertex Pharmaceuticals
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRegulatoryRemote work
$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...professional and timely manner.Accountable for US FDA submissions and approvals of project(s) of responsibility. May...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and... ...through large-scale Phase III/submission projects and global launch projects...SeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely... ...strong skills in eCTD publishing, and works well in...SeniorRegulatory
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring... ...qualifications: Expert in preparing and managing regulatory submissions with minimal guidance Skilled in analyzing complex...SeniorRegulatoryFull timeLocal area
- ...in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development... ...This hands-on role drives document readiness, eCTD publishing, cross-functional coordination with regulatory affairs...Regulatory
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
$193k - $210k
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers a competitive...SeniorRegulatory- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our team in Cambridge, Massachusetts. This role... ...6 years of medical writing experience, familiarity with regulatory submissions, and excellent project management skills. A comprehensive benefits...SeniorRegulatoryContract work
- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep... ...and experience coordinating multi‑team studies and regulatory submissions. #J-18808-Ljbffr RegeneronSeniorRegulatory
$83.3k - $95.9k
...Treasury Analyst 3, primarily located in Boston, Massachusetts, to lead daily global cash management and handle complex financial transactions.... ...settlements, preparing operational reports, and ensuring regulatory compliance. Wex offers competitive pay ranging from $83,300...SeniorRegulatory$100k - $143k
Relaytherapeutics in Cambridge, Massachusetts is looking for a motivated regulatory professional to join their regulatory team. In this role, you... ...pipeline, contributing to IND, CTA, NDA, and MAA submissions. Ideal candidates will have a B.S. or M.S., 2+ years of relevant...Regulatory- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...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- Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through... ...INDs/BLAs, prepare compilations, review dossiers for submission readiness, and guide cross-functional teams to ensure compliance...SeniorRegulatory
- ...preference for Boston, the role leads setup and delivery of global de novo RWE studies and... ...management tasks. As a senior member, you will manage... ...-to-end, oversee IRB/IEC submissions, budgets, and... ...analysis while upholding regulatory and #J-18808-Ljbffr Costello...SeniorRegulatory
- ...Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...Responsibilities: With some supervision, leads the execution of regulatory CMC... ...the development of robust and accurate submissions. Develops constructive relationships with...SeniorRegulatory
$178.1k - $244.86k
...PURPOSELead development and advancement of Global Patient Access (GPA) strategies across... ...ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle... ...compliant access globallyACCOUNTABILITIES Lead end-to-end strategy development and execution...SeniorRegulatoryMinimum wageTemporary workLocal areaNight shift- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology company... ...planning. This role is pivotal in leading regulatory interactions with... ...overseeing regulatory documentation and submissions for late-stage development,...SeniorRegulatory
- ...Attorney / Counsel - Junior / Senior / Lead Boston, Massachusetts,... ...specialized vertical in Legal, Regulatory Compliance, and Corporate... ...financial institutions, and global corporations and consultancies... ...impactful cases, regulatory submissions, process improvements,...SeniorRegulatoryContract work
$154.4k - $242.55k
...empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU... ..., MA reporting to the Senior Director, Head Inflammation... ...and documents submitted to Regulatory Agencies.• Establish and maintain... ...publications, regulatory submissions, and/or national or international...RegulatoryMinimum wageTemporary workLocal area$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout -... ...with vendor(s) to ensure timely submission and approvalActively track, enter and...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing... ...lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives...Regulatory
$106k - $130k
A biotech company is seeking a Regulatory Affairs Senior Associate in Boston. The role focuses on supporting regulatory activities for innovative therapeutics in neuromuscular conditions. Candidates should have a bachelor's degree in a scientific discipline, 2+ years in...SeniorRegulatory- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance for promotional materials across... ..., with global regulatory knowledge and experience in submissions and health authority interactions. A 70/30 in-person work model...Regulatory
- ...and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is... ...Area and supports manager and/or Global Regulatory Lead (GRL) in the... ...preparation and review of regulatory submissions consistent within US and Canada...SeniorRegulatoryLocal area
$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - Hematology Overview Cancer is unrelenting, but so... ...functional stakeholders in R&D, Global Medical Affairs, and Global Product... ...health authority interactions, regulatory submissions and key development milestones...SeniorRegulatoryLocal areaRemote workWork from home$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...through commercializationDrive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgencyLead...SeniorRegulatoryPermanent employmentFull timeWork at officeWork from home$137k - $215.27k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...as follows: With some supervision, leads the execution of regulatory CMC investigational... ...the development of robust and accurate submissions.Develops constructive relationships...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Publishing Lead — Global Submissions. Be the first to apply!
- senior operations associate Boston, MA
- senior safety specialist Boston, MA
- senior technology project manager Boston, MA
- senior c++ developer Boston, MA
- remote senior business analyst Boston, MA
- senior manager clinical operations Boston, MA
- senior supervisor Boston, MA
- senior leadership Boston, MA
- sr. process development engineer Boston, MA
- senior manager data science Boston, MA


