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
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Publishing Lead — Global Submissions in Boston, MA vacancy
$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- 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
- 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
- ...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
- ...forefront of medical innovation? As the Senior Global Medical Affairs Leader for MASH, you'll... ...Research & Development investment decisions, lead pre-launch scientific efforts, and... ...understanding of healthcare system pathways, regulatory landscapes, market access, and...SeniorRegulatoryFull timeWorldwideRelocation package
$212k - $333.19k
...knowledge.Job DescriptionAbout the role:The Senior Director, Oncology Search &... ..., translating scientific, clinical, regulatory, and competitive insights into actionable... ..., and a demonstrated ability to lead in a highly matrixed global environment. You will report to the...SeniorRegulatoryMinimum wageLocal areaRemote work- 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
- Parabilis is seeking a Senior Manager/Associate Director, Regulatory Operations to drive regulatory success and shape development... ...of life-changing treatments. You will lead global regulatory submissions, information management, publishing, and Health Authority interactions...Regulatory
- 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
- ...Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract... ...mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorRegulatoryContract work
- Moderna is seeking a Global Regulatory CMC Lead to coordinate CMC activities across product lifecycles and develop global regulatory strategies... ..., strong collaboration skills, and the ability to drive submissions through health authorities while maintaining alignment...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
- .../ Counsel - Junior / Senior / LeadBoston, Massachusetts... ...JobCatalyst Labs is a leading talent agency with a... ...vertical in Legal, Regulatory Compliance, and Corporate... ...institutions, and global corporations and consultancies... ...cases, regulatory submissions, process improvements,...SeniorRegulatoryContract work
Catalyst Labs, LLC
Boston, MA1 day ago - Moderna Therapeutics seeks a Sr. Director of Regulatory Strategy to support oncology programs... ...strategist will develop and execute global plans, articulate compelling strategies... ...for a novel mRNA modality. The role leads submissions, advises development teams, and maintains...SeniorRegulatory
- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology company... ...a hands-on approach, capable of leading the team in interactions with global... ...regulatory documentation and submissions, providing strategic direction for...SeniorRegulatory
- ...Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in Cambridge... ...cross‑functionally to ensure compliant submissions and timely milestones. You will manage INDs...Regulatory
- 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
$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- ...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
- Immuneering Corporation in Cambridge, MA seeks a Director of Regulatory CMC to lead global CMC regulatory strategies for investigational and commercial products. You will prepare and submit CMC sections for INDs, NDAs, and other filings, interfacing with FDA/EMA and cross...RegulatoryRemote job
$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- ...Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution... ...Medical Officer, you will serve as the Global Regulatory Lead on program teams and... ...will translate strategy into regulatory submissions, briefing materials, and agency...Regulatory
$85 - $92 per hour
Job Description The Regulatory Publishing Senior Manager is responsible for the creation, assembly... ..., and publishing of electronic submissions and the delivery to global health authorities in an... ...manner. The role is accountable for leading publishing activities on a portfolio...SeniorRegulatoryContract workMonday to FridayShift work- ...Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs. The role requires 8+ years in regulatory affairs, strong...Regulatory
- ...seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... ...will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...Regulatory
$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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Publishing Lead — Global Submissions. Be the first to apply!
Related searches
- senior network engineer remote Boston, MA
- senior app developer Boston, MA
- senior manager legal Boston, MA
- sr project manager Boston, MA
- senior account executive Boston, MA
- senior manager strategic initiatives Boston, MA
- senior staff systems engineer Boston, MA
- senior commercial counsel Boston, MA
- senior data manager Boston, MA
- sr. hr generalist Boston, MA