Global Regulatory Submissions Lead
Jobleads-US
Merida Biosciences is seeking an Associate Director of Regulatory Affairs Operations. This hands-on leader will drive regulatory submission planning, execution, and lifecycle management across development programs, partnering with Regulatory Affairs leadership and cross-functional teams to ensure timely, high-quality submissions.
The role requires 7+ years in Regulatory Affairs/Operations, deep experience with RIMS/EDMS/eCTD, Veeva Vault, and strong project management.
#J-18808-Ljbffr Jobleads-US- Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs. This hands-on role drives document readiness, eCTD publishing, cross-functional coordination...Regulatory
$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- 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...RegulatoryRemote work
$177k - $278.08k
...lasting impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...you will set global regulatory strategy and lead major submissions for high-impact oncology programs.How you will contribute:...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$154.4k - $242.55k
...and empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge... ...protocols and documents submitted to Regulatory Agencies.• Establish and maintain... ...evidenced by 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
- 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
$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office... ...to simultaneously driving regulatory approval as well as launch and global... ...pathways through large-scale Phase III/submission projects and global launch projects.Links...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... ...will guide product teams and prepare CMC/Quality regulatory submissions with stakeholders to drive timely approvals. The role...Regulatory
- ...Cambridge, MA is seeking a Director or Senior Director of Regulatory Strategy to lead the global regulatory strategy for clinical and pipeline programs. The successful candidate will oversee regulatory submissions, manage relationships with regulatory authorities, and...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
- ...is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development... ...on Human Factors, regulatory submissions, and cross-functional collaboration.... ...regulatory strategies, interfacing with global health authorities, and ensuring high...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional materials comply... ..., and Commercial teams, guiding advertising strategies and submissions, including 2253 filings, with emphasis on OPDP/APLB guidance...Regulatory
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...Regulatory
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
$154.4k - $242.55k
...Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies... ...and liaises with regulatory team members in evolving submission and negotiation plans. Formulating regulatory labeling...RegulatoryMinimum wageTemporary workLocal area- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for... ...qualifications: Expert in preparing and managing regulatory submissions with minimal guidance Skilled in analyzing complex data...RegulatoryFull timeLocal area
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion... ...across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership and collaboration...RegulatoryWorldwide$169.4k - $266.2k
...deliver your best. As part of the Global Medical Affairs Oncology team... ...Communications Group Lead. This is a hybrid role based... ...slide decks, NCCN or pathway submissions, animations, and digital amplification... ...sub-analysesCompliance and Regulatory: Excellent understanding of...RegulatoryMinimum wageTemporary workFor contractorsFreelanceLocal areaRemote work$144.5k - $195.5k
The Global Study Lead (Sr. Manager, Clinical Operations) is responsible for leading the operational planning and execution of global clinical... ...Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting...RegulatoryFull timeTemporary workLocal areaRemote workFlexible hours$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...RegulatoryMinimum wageTemporary workLocal areaNight shift$154.4k - $242.55k
...the best of my knowledge.Job DescriptionAbout the Role:The Global Brand Lead, ITP (Associate Director) is responsible for driving global... ...indications. This role partners closely with Medical, Legal, and Regulatory teams to ensure materials are compliant, impactful, and...RegulatoryMinimum wageTemporary workLocal areaRemote work- ...challenge the status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases... ...US HEOR for the Americas, this role will lead the development and implementation of... ...Review Committee (Legal/Medical/Regulatory) and experience with VeevaVault or similar...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...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...Regulatory
$192.4k - $302.39k
...that will inspire you and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA office.At Takeda, we are... ...incorporating cross-functional strategies (e.g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes, Market Access, DD&T,...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...RegulatoryRemote work
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