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 BioSpace
- 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 for the Director...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
$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, we are... ...Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team.... ...pharmaceutical industry, including regulatory requirements and... ..., MA Seniority level Director Employment type Full-...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- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...
$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...- ...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
$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... ...What You’ll Do Serve as global regulatory lead accountable for all regulatory aspects...Permanent employmentWork at officeWork from home- ...USA Job Overview Join our global diversified... ...Role Summary The Senior Director of Advertising & Promotion - Regulatory Affairs for drug and device... ...Canadian action letters and leads the company in discussions... ...management experience required. GI experience - preferred....Geographic information systemTemporary workWork at officeFlexible hours
- Vertex Pharmaceuticals is seeking a Regulatory Strategy Senior Director to lead regulatory approaches for various projects. The role, located in Boston, is hybrid, requiring 3 days per week onsite. The ideal candidate will possess significant expertise in regulatory affairs...3 days per week
$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- ...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
- 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...
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...
$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$210k - $235k
Vor Bio is looking for a Director of Regulatory Strategy in Boston, MA. This role involves global leadership in regulatory strategy for developmental programs in immunology. The Director will work closely with cross-functional teams to ensure compliance and effectively...Remote jobFlexible hours- Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements. You will influence senior...Work at officeRelocation
- A global biopharmaceutical company is seeking a Director of Regulatory Affairs to lead the Global Regulatory Strategy. This role involves developing strategies for securing market approval, ensuring compliance with regulatory requirements, and mentoring team members. Candidates...
- MBX Biosciences is seeking a Director of Regulatory Affairs to lead global regulatory strategies for its clinical stage programs, including INDs and CTAs, in alignment with health authority expectations. The role provides strategic regulatory leadership across early development...
- Beeline Medicines in the United States is seeking an Executive Director, Regulatory Affairs to serve as Global Regulatory Lead for assigned programs and report to the Senior VP, Regulatory Affairs & Quality. You will drive global regulatory strategy, oversee submissions...For contractors
- 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...
- ...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
- 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....
- Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!) Overview A growing oncology biotech is seeking a Director / Senior Director, Global Regulatory Lead to drive global regulatory...Relocation3 days per week
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