Director, Global Regulatory Lead - GI & Inflammation
$174.5k - $274.23kBioSpace
A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams, and ensuring compliance with FDA regulations. Candidates should have over 8 years of pharmaceutical experience, with a strong background in regulatory affairs. This position is classified as hybrid, offering an attractive salary range between $174,500 and $274,230. #J-18808-Ljbffr
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, while maintaining the currency of...Geographic information systemFull timeLocal area
$154.4k - $242.55k
...you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge... ...MA reporting to the Senior Director, Head Inflammation... ...Team (TST) and partners with GI-DDU research, physician scientists... ...documents submitted to Regulatory Agencies.• Establish and...Geographic information systemMinimum wageTemporary workLocal area- 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 regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Geographic information system
$154.4k - $242.55k
...DescriptionObjective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives... ...counterparts.Accountabilities:The Associate Director will be responsible for complex or highly complex or...Geographic information systemMinimum wageTemporary workLocal areaRemote work- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...Suggested
$167k - $300.7k
...The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within... ...Director will be a strategic leader within Global Regulatory Science, responsible for... ...You’ll Do: Serve as global regulatory lead accountable for all regulatory aspects...Permanent employmentFull timeWork at officeWork from home$177k - $278.08k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration...Minimum wageTemporary workLocal areaRemote workWorldwide$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 programs, with a focus on immunology. The ideal candidate will be responsible for developing and executing...$196.7k - $353.4k
...The Role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development...Permanent employmentFull timeWork at officeWork from home- ...Job Title: Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy Responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory...
$212k - $333.19k
...life‑changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human... ...thereby driving prospective and proactive implementation. Globally influence and serve as a key opinion leader and...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-... ...major regions (e.g., US, EU, Japan, China).ACCOUNTABILITIES Leads and develops a team of regulatory leaders and subject matter...Minimum wageTemporary workLocal areaRemote work$238k - $374k
...life-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you... ...(e.g., US, EU, UK, Japan, China).How you will contribute:Leads and develops a team of regulatory leaders and subject matter...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$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...Minimum wageTemporary workLocal areaNight shift- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust...
- ...will possess expertise in drafting label content and leading cross-functional teams within a larger development... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development...Local area
- ...team that feels personal even though it's over 54,000 strong. As a Global Cloud Elite and Platinum member of the Oracle Partner Network... ...Oracle practice (.)You Are:A senior Oracle Utilities Integration Lead who brings both the architectural vision and the hands-on...Geographic information systemFull timeWork experience placementLive inWork at officeLocal areaRemote work
- A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience... ..., to ensure alignment between US and global strategies. Exceptional communication...
- ...Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the... ...messenger RNA technology in the US and other global markets. Responsibilities Serve as the global regulatory lead delegate for development compounds in the oncology...
- ...devastating diseases. We have built a world-leading drug design engine comprising AI... ...The experienced and visionary Head of Global Regulatory Affairs and Strategy will lead... ...BLA/MAA), preferably with oncology and inflammation experience. Track record: Extensive experience...Work at office3 days per week
- ...MIT Investment Management Company (MITIMCo) seeks an Associate Director for Global Investment Legal Services to lead the legal review of investments in private funds, co-investments and separately managed accounts, working with GIS and other MIT teams. You will draft...Geographic information system
- ...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...Hourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
$206.25k - $297.92k
Job title: Global Lead, Scientific Platforms & Engagement StrategyLocation: Cambridge, MA, Morristown, NJAbout the JobAt Sanofi, we chase... ...all scientific platforms and AI-generated content meet regulatory, medical-legal-regulatory (MLR) review, and ethical standards...Full time$177k - $278.08k
...all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:Global Brand Lead, IgAN (Director level), reporting to the Global Commercial Lead, IgAN, is responsible for leading the global commercialization...Minimum 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 Quality, Regulatory, Medical Director.Maintain knowledge base as to developments...Minimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$124k - $186k
...to learn more about life at Klaviyo? Visit klaviyo.com/careers to see how we empower creators to own their own destiny.The Global Onboarding Lead will play a critical role in building and running the global onboarding experience that sets every new Klaviyo up to drive...Work at office$154.4k - $242.55k
...best of my knowledge.Job DescriptionAbout the Role:The Global Brand Lead, ITP (Associate Director) is responsible for driving global commercial... .... This role partners closely with Medical, Legal, and Regulatory teams to ensure materials are compliant, impactful, and...Minimum wageTemporary workLocal areaRemote work$178.5k - $257.83k
Job title: Global Lead, Innovation Expansion & AdoptionLocation: Cambridge, MA, Morristown, NJAbout the JobAt Sanofi, we chase the miracles... ...scaling strategies are adapted for local market contexts, regulatory requirements, and operational capabilities.Develop Hub-...Permanent employmentFull timeLocal areaWorldwide$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...Full timeTemporary workLocal areaRemote workFlexible hours$206.25k - $297.92k
Job title: Global Lead, Medical Intelligence to StrategyLocation: Cambridge, MA, Morristown, NJAbout the JobAt Sanofi, we chase the miracles of science to improve people's lives. We are accelerating Sanofi's modernization journey, supporting our Take the Lead strategy to...Full timeShift work
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