Regulatory Affairs Manager — Gene Editing Therapeutics
Arbor Biotechnologies
Arbor Biotechnologies, based in Cambridge, MA, is seeking a Manager, Regulatory Affairs to support an expanding gene editing programs portfolio. You will lead regulatory execution across development programs, health authority interactions, and cross-functional teams to advance IND/CTA submissions. The role is hybrid, based in the Cambridge area, with collaboration across Clinical, CMC, Quality, and Program Management. Strong writing and organizational skills are essential. #J-18808-Ljbffr Arbor Biotechnologies
- Arbor Biotechnologies, based in Cambridge, MA, is seeking a Manager, Regulatory Affairs, to support regulatory execution across internal and partnered programs, health authority interactions, and cross-functional activities toward IND/CTA submissions. You will lead regulatory...Suggested
$115k - $135k
...Biotechnologies, a next-generation gene editing company based in Cambridge, MA, is advancing... ...a pipeline of novel gene editing therapeutics to address a wide range of genetic... ...Arbor Biotechnologies is seeking a Manager, Regulatory Affairs, to support an expanding portfolio...Suggested- ...Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies for gene therapy products. This full-time... ..., Massachusetts involves managing post-approval regulatory... ...strong background in CMC regulatory affairs, demonstrating exceptional communication...SuggestedFull time
- ...a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and... ..., Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is responsible...SuggestedLocal area
$187k - $253k
...Strategic Sourcing has responsibility for managing and optimizing external spending... ...business stakeholders in the creation, editing and implementation of contracts.Ability... ...About AlnylamWe are the leader in RNAi therapeutics – a revolutionary approach with the potential...SuggestedFull timeContract workTemporary workLocal areaFlexible hours$212k - $318k
...medicines for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-... ...in insulin and technologies for insulin management have helped people with T1D manage their... ...with HEOR, International P&R, Corporate Affairs, US Managed Markets, Countries, Marketing...Full timeSummer workRemote workFlexible hours2 days per week$268.2k - $402.2k
...DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned... ...the T1D portfolio. This position will manage a group of global/regional regulatory... ...management on status of global Regulatory Affairs strategies and tactics, procedures and...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$163.5k - $281.6k
...how health is understood and managed, and support the communities... ...strategic Director/Senior Director, Regulatory CMC to lead and execute... ...strategies for our cutting-edge gene therapy portfolio. This role... ...gene therapies and advanced therapeutic medicinal products (ATMPs)....For contractorsWork at officeFlexible hours- 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...
$251.77k - $307.72k
...develop curative genome editing treatments that can... ...maturing the quality management system and digital compliance... ...compliance with regulatory requirements, industry... ...modalities (cell and gene) and geographiesProvide... ...skillsExperience across multiple therapeutic modalities (small...Full time$160.8k - $201k
...therapy and the first ever gene therapy to treat... ...The Associate Director, Regulatory Labeling and... ...posting on Health Authority-managed databases worldwide (e... ...the Global Regulatory Affairs team, cross functional... ...work in the U.S.Sarepta Therapeutics offers a competitive compensation...Full timeWork at officeLocal areaImmediate startWorldwide$186.23k - $279.35k
...about science and experienced within regulatory affairs and drug development? Do you possess strategic... ..., commercialization and life cycle management of assigned products. Serves as the... ...the regulatory strategy for our therapeutic assets, and engage with Health Authorities...Hourly payFull timeTemporary workWorldwide3 days per week- ...DescriptionGeneral Summary:The Regulatory Labeling Director will lead... ...product labeling across a therapeutic area. This will include target... ...development and lifecycle management of labeling for that/those area... ...of experience in regulatory affairs in the area of global...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...driven choices.Delivery and Milestone Management: Oversee all regulatory deliverables... ...product development in the following therapeutic areas: oncology, autoimmune, rare...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$167k - $300.7k
...Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within... .... Prior regulatory experience with therapeutics development is preferred.Here's What You... ...Team, Project Development Team and senior management, as relevant.Collaborates with internal...Permanent employmentFull timeWork at officeWork from home- ...are capable of working across multiple therapeutic areas and drug modalities. We are... ...experienced and visionary Head of Global Regulatory Affairs and Strategy will lead regulatory strategy... ...Technical Document (eCTD) document management and submission planning. Architect and...Work at office3 days per week
- ...innovative biotechnology company in the search for a Senior Director, Regulatory Affairs . This fully remote role (US or Canada) will lead regulatory... ...and modalities, including small molecules, biologics, and gene therapies. Prior leadership and mentoring experience, or...Remote work
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations:... ...BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise... ...interpretation; coordinate across therapeutic areas and regulatory teams to deliver...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$137k - $215.27k
...patients. By focusing R&D efforts on four therapeutic areas and other targeted investments,... ....This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls... ...some supervision, plans, executes and manages regulatory submissions according to the...Minimum wageTemporary workLocal areaRemote workWorldwide$100k - $143k
The Opportunity:We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx.... ...experience, skills and location.#JO1About Relay TherapeuticsRelay Therapeutics is a clinical-stage precision medicines company transforming...$177k - $278.08k
...patients. By focusing R&D efforts on four therapeutic areas and other targeted investments,... ...worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing... ...Ensures project team colleagues, line management, and key stakeholders are apprised of...Minimum wageTemporary workLocal areaRemote workWorldwide- ...We are seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be responsible for developing... ...activities across a variety of projects and therapeutic areas. Key Responsibilities: Develop and implement...Contract workWork at office
$275k - $315k
Position OverviewBicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline... ...BLA submission and approval. You will manage a small team of Regulatory Affairs...Full timeTemporary workWork at officeLocal area3 days per week$180k - $245k
OverviewMonte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development... ...development through approval and lifecycle management.Ensure regulatory strategies align with...$209.35k - $258.6k
Regulatory AffairsCambridge, MA • ID: 26R-19 • Full-Time/RegularThis position is currently... ...status quo and work to develop unique therapeutics that have the potential to set new... ...?Job Summary:The Director, Regulatory Affairs - Labeling is a highly visible leadership...Full timeWork at officeLocal areaRelocationFlexible hours$145k - $215k
...disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for... ...make an impact:Kymera Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory contributor and emerging strategic...$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote... ...disease. At Travere Therapeutics, we recognize that our exceptional... ...The Director, Regulatory Affairs Strategy is responsible for... ...programs ~ Demonstrated success managing interactions with FDA and...Temporary workLocal areaRemote workWeekend work- ...Job Title: Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy... ...for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product... ...with global regulatory requirements, and manages compounds through all phases of...
$150k
Premier Research is looking for a Regulatory Strategy, Director (Bay Area, Boston) to join our Regulatory Affairs team.You will help biotech, medtech, and specialty pharma... ...and late stage, post-approval) in various therapeutic areas and product types (drugs, biologics,...Full time- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical... ...transformative gene-based medicines for serious... ...leadership in gene editing through the... ...required. Ability to manage multiple priorities within...Contract workRemote work
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