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
$174.5k - $274.23k
...Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives... ...regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex...Geographic information systemMinimum wageFull timeTemporary workLocal areaRemote work$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
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus on...SuggestedLocal areaFlexible hours2 days per week$208.2k - $327.14k
...Global Therapeutic Research Lead - Immunology Job Description At Takeda... ...Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team.... ...pharmaceutical industry, including regulatory requirements and... ...Seniority level Director Employment type...Geographic information systemFull timeTemporary workFor contractorsLocal areaRemote workWorldwide- 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...
$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 will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...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...- ...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$167k - $300.7k
The Role: Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within... ...will be a strategic leader within Global Regulatory Science, responsible for developing... ...You’ll Do: Serve as global regulatory lead accountable for all regulatory aspects...Permanent employmentWork at office- 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
- Beeline Medicines in Boston is seeking a Director of Regulatory Strategy to lead the global regulatory strategies for early-stage and pipeline programs in the immune and inflammation (I&I) therapeutic area. The role requires at least 10 years of regulatory experience, focusing...
- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities....
- ...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...
- 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...
- ...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
- ...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
- ...to continuously challenge the status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group’s business... ...more here.Who we are looking forThis is what you will doThe Lead, Pricing & Planning, Global Rare Diseases will serve as the...Hourly payContract workLocal areaRemote workRelocation packageFlexible hoursShift work
$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,...Minimum wageTemporary workWork at officeLocal areaRemote work$148.5k - $214.5k
Job title: Global Scientific Communications Lead Rare Diseases (Systemic Mastocytosis)Location: Cambridge, MAAbout the JobWe are an innovative global... ...people’s lives.Main Responsibilities:The Associate Director, will work closely with external thought leaders and internal...Full time$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- ...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
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