Global Quality Director, R&D & Regulatory Readiness
Skills Alliance Enterprise
A biotechnology organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong background in project management and quality systems, preferably within the pharmaceutical industry. The position offers a competitive salary and may require up to 15% travel. #J-18808-Ljbffr Skills Alliance Enterprise
$160.6k - $240.8k
Job Description The Associate Director, R&D Quality Regulatory & Risk Integration is responsible for establishing... ..., governance processes, and inspection readiness activities across R&D Quality. The role partners closely with Global Regulatory Intelligence & Surveillance...SuggestedRemote workFlexible hours2 days per week$160.6k - $240.8k
...Position Summary Associate Director responsible for establishing... ..., and maturing the R&D Quality Regulatory Intelligence & Surveillance... ...insights, recommendations, and readiness strategies. Integrate RI&S... ...inspection trends, and emerging global expectations. Pay/...Suggested$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be required. We are partnered... ...role ensures alignment with international regulatory standards while driving inspection readiness, vendor oversight, proactive risk governance,...SuggestedWork experience placementRemote workWorldwideShift work- Vertex Pharmaceuticals is looking for an Associate Director, R&D Quality Regulatory & Risk Integration in Boston. This role is responsible for establishing... ...a solid understanding of GxP regulations and inspection readiness. You will manage key responsibilities such as...Suggested
$238k - $374k
...forward‑looking, world‑class R&D organization that unlocks... ...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early... ...combination where applicable, quality, clinical, and manufacturing... ...formulation changes, analytical readiness, control strategy evolution...SuggestedFull timeTemporary workLocal areaWorldwide$238k - $374k
...forward‑looking, world‑class R&D organization that unlocks... ...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug... ..., combination product, quality, clinical, development and manufacturing... ...compliant, inspection‑ready processes and documentation....Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$212k - $333.19k
...forward-looking, world-class R&D organization that unlocks... .... Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you... ...through registration and launch readiness for high-impact oncology... ...executed on time with high quality, including major...Minimum wageTemporary workLocal areaWorldwide- ...Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is... ...related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development...Temporary workWorldwide
- Scholar Rock is looking for a Director of Quality Systems and GxP Compliance in Cambridge, MA. This... ...role overseeing quality systems and regulatory compliance across commercial, clinical... ...while supporting compliance and inspection readiness. #J-18808-Ljbffr Scholar Rock
$177k - $278.08k
...we are a forward‑looking, world‑class R&D organization that unlocks innovation and... ...patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ..., timely delivery, and adherence to quality standards. Continuous Improvement...Full timeTemporary workLocal areaWorldwide- Vertex Pharmaceuticals Incorporated is seeking a Senior Director, Global Quality Systems to lead and enhance the Quality Management System. This... ...role requires substantial leadership experience, strong regulatory compliance expertise, and a commitment to quality culture...Flexible hours
$247.2k - $334.4k
The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient, high-quality decision-making on regulatory pathways... ...involving U.S. and global regulatory pathways, product... ..., inspection readiness, and human subject research...Full timeTemporary workLocal areaFlexible hours- Chief of Staff, Senior Director Global Regulatory Affairs The Chief of Staff (CoS... ...early to protect timelines and quality. Cross-Functional and... ...Coordination: Partner across R&D, Commercial, Safety, Medical... ...issues that impact filing readiness and approvals. Organizational...Hourly payTemporary workWork at office
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...profiles, development pathway viability, and filing readiness. Maintain appropriate trackers of regulatory...Local areaFlexible hours2 days per week- ..., we are a forward‑looking, world‑class R&D organization that unlocks innovation and... ...About the Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...Development, Analytical Development, Production, Quality Assurance can be considered. Strong...Full timeLocal areaWorldwide
- Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!) Overview... ..., including planning, execution, and submission readiness Partner cross-functionally with Clinical, CMC,...Relocation3 days per week
$177k - $278.08k
...we are a forward‑looking, world‑class R&D organization that unlocks innovation and... ...patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...types are executed on time with high quality, including major submissions (NDA/BLA/...Minimum wageFull timeTemporary workLocal areaWorldwide$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...$215k - $260k
...Manufacturing Co is seeking a Senior Director, U.S. Quality to oversee and execute the Quality Management... ...S. business, ensuring compliance with regulatory requirements and operational... ...collaborate cross-functionally, adapting global quality policies to local needs. This...Local area$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 and...Permanent employment- Join to apply for the Associate Director, R&D Quality role at BioSpace We are seeking a highly motivated... ...candidate will strengthen inspection readiness, harmonize processes and job aids, and... ...work. That’s why our US benefits and global well-being resources are designed to...Work from home
- 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...
$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$189k - $246k
Travere 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 3 drug development programs. As the regulatory lead, you will ensure compliance,...Remote job- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling content and strategy for multiple products in various stages of drug development. The role requires 10+ years of pharmaceutical...
- A global pharmaceutical company is seeking a Director of Regulatory Affairs to lead the development and implementation of global regulatory strategies for products in Boston. The ideal candidate will have over 5 years of regulatory experience, specifically in a strategic...
- AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-mediated and rare diseases. You will drive Health Authority engagements, submissions, and labeling, mentor cross...
- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. The Associate Director, Global...Full timeRemote workWorldwide
- # Director, Portfolio Strategy - Global InitiativesFlagship PioneeringDirectorVenture CapitalHealthcare, Biotech... ...a differentiated BioMedicines R&D portfolio from early discovery through... ...clinical development and commercialization readiness.The role partners closely with...
- Alnylam Pharmaceuticals is seeking a Senior Legal Director, R&D and Regulatory Counsel responsible for providing strategic legal counsel on regulatory pathways and product development. This role supports key pipeline assets and collaborates across teams to manage legal...
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