Director, Global Regulatory Lead - GI & Inflammation
BioSpace
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
...Director, Global Regulatory Lead, GI & Inflammation Join to apply for the Director, Global Regulatory Lead, GI & Inflammation role at BioSpace Director, Global Regulatory Lead, GI & Inflammation 16 hours ago Be among the first 25 applicants Join to apply...Geographic information systemMinimum wage16 hoursFull 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
- ...A leading biopharmaceutical company is seeking a Director of Global Regulatory Strategy to lead strategies and ensure compliance with regulatory requirements. You will oversee FDA submissions, manage Global Regulatory Teams, and contribute to cross-functional projects...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...Local 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$177k - $278.08k
...changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...functions as follows: You will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory CMC strategy...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$177k - $278.08k
Job Description Director, Global Regulatory Lead Oncology - responsible for setting global regulatory strategy and leading major submissions for high‑impact oncology programs. About the role Oversee and execute all regulatory activities of one or multiple complex projects...Temporary workLocal areaRemote work- Hasbro in Boston, MA, is seeking a Director of Global Trade Compliance to shape and execute our strategy across global operations, ensuring world-class compliance and risk management. You will lead a distributed team of 12 professionals, drive adherence to CTPAT, ISA,...
$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$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...$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$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$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- ...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
$189k - $246k
...Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase... ...development programs. As the regulatory lead, you will ensure compliance, manage interactions...Remote job- Vertex Pharmaceuticals Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule portfolio. You will guide content for submissions, engage Health Authorities...
$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 employmentWork at officeWork from home- 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...
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early-stage immunology and inflammation programs, including lupus. You will guide development teams and coordinate across FDA...
- ...please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing global strategies to...Temporary workWorldwide
- ...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...
- ...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
- ...Sanofi is seeking a Global Medical Director Stakeholder Engagement (Immunology) to lead TA engagement strategy across Derm/Rheum or Resp/GI areas, coordinating with global medical societies and key scientific leaders. The role combines strategic influence with hands‑on...Geographic information system
$240k - $360k
...serious, progressive, autoimmune disease of the kidney that can lead to end-stage-renal disease. IgAN is the most common cause of... ...myasthenia gravis (gMG). Vertex is seeking a Senior Director of Global Value & Access Strategy (GVAS) for povetacicept, reporting to...Summer workRemote workWorldwideFlexible hours2 days per week
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