Global Regulatory Lead, Gene Editing Programs
Arbor Biotechnologies
Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead global regulatory strategy across our preclinical and early clinical portfolio, reporting to the Chief Medical Officer. You will be the primary regulatory contact with FDA and other health authorities, drive designations, plan submissions, and coordinate CROs, medical writers, and consultants to align with development plans. #J-18808-Ljbffr Arbor Biotechnologies
- ...Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical programs. Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on program teams and as the...Regulatory
$212k - $333.19k
...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 global patient... ...modalities such as Cell Therapy or Gene Therapy, large scale programs through...RegulatoryMinimum wageWork at officeLocal areaRemote work$150k - $165k
...everything possible.The Senior Program Manager, Plasmid DNA is responsible for leading Aldevron's most strategic and... ...Qualification (PPQ), regulatory readiness, and commercial launch... ...manufacturing and its use in cell and gene therapy, gene editing, mRNA, vaccines, or other...RegulatoryFull timeRemote workWork from homeFlexible hoursNight shift$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... ...and lead major submissions for high-impact oncology programs.How you will contribute:Oversee as well as execute all regulatory...RegulatoryMinimum wageLocal areaRemote workWorldwide$177k - $278.08k
...role, you will help shape the global commercial strategy for an... ...bring a broad commercial and program perspective to complex scientific... ..., treatment changes, regulatory pathways, and potential commercialization... ....Demonstrated ability to lead globally across functions,...RegulatoryMinimum wageLocal area- Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in Cambridge, MA or San Francisco, CA, you will partner cross‑functionally to ensure compliant submissions...Regulatory
$178.5k - $257.83k
Job title: Global Periodic Reporting leadLocation: Cambridge, MA... ...As Global Periodic Reporting Lead within our Pharmacovigilance... ...managing the annual worldwide regulatory planning of PSRs for the entire... ..., prevention and wellness programs and at least 14 weeks’ gender...RegulatoryFull timeWorldwide$177k - $278.08k
...of the R&D Procurement team, leading category strategy and a team... ...investmentLead complex strategic programs and category value plans,... ...support business objectives, regulatory requirements, quality standards... ...:As members of Global Procurement, you are expected...RegulatoryMinimum wageContract workLocal area$136.4k - $253.2k
...Data Science is recognized as a leading hub for top industry talent,... ...agile workforce to deliver regulatory commitments across the portfolio... ..., and align statistical programming practices across both early-... ...support internal audits and global health authority inspectionsYou...RegulatoryFull timeLocal area- ...medical innovation? As the Senior Global Medical Affairs Leader for... ...investment decisions, lead pre-launch scientific efforts... ...healthcare system pathways, regulatory landscapes, market access, and... ...and real-world evidence (RWE) programs. They shape and drive groundbreaking...RegulatoryFull timeWorldwideRelocation package
$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA... ...strategies (e.g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes, Market... .... These may include interactive programs, behavioral therapy modules, and educational...RegulatoryMinimum wageWork at officeLocal areaRemote work$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...Prothromplex and subsequent scientific programs and related medical activities.Strategically... ...Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout -...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$210.9k - $379.2k
...diverse pipeline of development programs across various diseases.As an... ...worldwide, contributing to global health initiatives.Moderna's... ...is seeking a Global Medical Lead to lead medical affairs strategy... ...interface extensively with regulatory, clinical, commercial, and external...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide$169.4k - $266.2k
...assigned neuroscience assets and programs. You will play a key role in... ...scientific exchange across global audiences. You will be part... ...professional engagement objectives. Lead scientific content... ...by partnering with Legal and Regulatory colleagues to support accurate...RegulatoryMinimum wageFull timeLocal area$122.25k - $176.58k
Job title: GRA Global AdPromo Excellence LeadLocation: Morristown, NJ - Cambridge, MAAbout... ...support for global promotional material regulatory review (30%) with transversal excellence... ...GRA AdPromo in transformation programs and cross-functional initiativesSupport...RegulatoryFull timeWork at officeLocal areaWorldwide$169.4k - $266.2k
...support assigned products or programs. You will play a key role in... ...formats. You will be part of a global, cross-functional environment... ...engagement objectives. Lead scientific content development... ...by partnering with Legal and Regulatory colleagues to support accurate...RegulatoryMinimum wageFull timeLocal areaWorldwide- ...Boston, MA is seeking an experienced GRA CMC Product Lead to develop and oversee regulatory CMC strategies for assigned products, guiding submissions... ...CMC members, and drive regulatory compliance across global programs in a hybrid work model. #J-18808-Ljbffr Jobleads-...Regulatory
$169.4k - $266.2k
...assigned neuroscience assets and programs. You will play a key role in... ...scientific exchange across global audiences. You will be part... ...professional engagement objectives. Lead scientific content... ...by partnering with Legal and Regulatory colleagues to support accurate...RegulatoryMinimum wageFull timeLocal areaWorldwide$177k - $278.08k
...of the R&D Procurement team, leading category strategy and a team... ...investment Lead complex strategic programs and category value plans,... ...support business objectives, regulatory requirements, quality... ...advantage As members of Global Procurement, you are expected...RegulatoryMinimum wageFull timeContract workLocal area- ...currently seeking to recruit an experienced Global Asset Lead (GAL) to take end‐to‐end... ...successful delivery of a priority oncology program. In this pivotal role, you will lead a... ...integrating the efforts of Clinical, Regulatory, CMC, Medical Affairs, and Commercial...RegulatoryShift work
$177k - $278.08k
...several innovative medicines globally. We are looking for a leader... ...the Global Launch Excellence Lead, you will work with a Product... ...Clinical Development, Global Regulatory Affairs, Global Manufacturing... ...Collaborate with the Global Program Manager (GPM) and regional launch...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwideFlexible hours$232.5k - $320k
## Global Brand Lead, NavtemadlinPostuler: Cambridge (US): Temps complet: Offre publiée aujourd... ...across Medical, Market Access, Regulatory, Insights, Finance, Supply, Legal, Business... ...participate in our short-term incentives program. At Ipsen we are proud to offer a...RegulatoryTemporary workLocal areaFlexible hours$212k - $333.19k
..., 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... ...pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company...RegulatoryMinimum wageLocal areaRemote work- ...Bedford, MA seeks an Innovation Program Management Leader for Advanced Imaging to lead a complex medical device platform... ..., electronics, software, regulatory readiness, manufacturing readiness... ...releases, ensuring alignment across globally distributed teams, managing dependencies...Regulatory
$192.4k - $302.39k
...you to shine? Join us as a Director, Global Medical Lead, Zasocitinib- Psoriatic Arthritis (PsA... ...while recognizing local practice, access, regulatory, and stakeholder needs.Model Takeda... ...and reputational risks across the PsA program.Champion responsible use of digital, data...RegulatoryMinimum wageWork at officeLocal areaRemote work- Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings...Regulatory
- ClinLab Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program, reducing reliance on external consultants and closing timeline gaps created by competing...Regulatory
$192.4k - $302.39k
...best of my knowledge.Job DescriptionThe Global Medical Affairs Lead, PDT Immunology is responsible for co... ...D, Global Medical Affairs, clinical, regulatory, safety, compliance, regional and... ...pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company...RegulatoryMinimum wageLocal areaRemote work- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning... ...role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs, ensuring compliance and efficiency. Ideal...RegulatoryRemote job
- Takeda seeks a Global Medical Lead, Nephrology for the Cambridge, MA area to drive end-to-end medical... ...functional execution across Clinical, Regulatory and Commercial partners. You will lead... ...to advance IgAN and mezagitamab programs. #J-18808-Ljbffr USA - 3316 Takeda Development...Regulatory
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