- Triton Medical Robotics (Burlingame, CA)
- …We have a fantastic team, technology, and investors. Title: Vice President of Quality Assurance & Regulatory Affairs POSITION SUMMARY: The company is seeking ... of the executive team and responsible for determining and achieving the company's quality and regulatory goals. In this role, you will maintain and improve the … more
- Dennis Partners (Boston, MA)
- …for multiple neurodegenerative diseases. They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead both functions, and serve as ... providers used to support the clinical development programs.Build a strong Regulatory Affairs and Quality team to meet the needs of the clinical development… more
- Pulmonx Corporation (Redwood City, CA)
- Vice President, Regulatory Affairs & Quality AssuranceThe Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies ... directly and through in-country representatives.Responsibilities and CapabilitiesDefine and lead the Regulatory and Quality strategies for the company, including… more
- Xilio Therapeutics (Waltham, MA)
- Vice President, Regulatory Affairs and Quality Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated ... follow us on LinkedIn (Xilio Therapeutics, Inc.) SUMMARY: The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across… more
- Pliantrx (San Francisco, CA)
- Director, Regulatory Affairs and Quality Project ManagementPliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development ... of physicians, patients, and families impacted by fibrotic diseases.DescriptionThe Director of Regulatory Affairs and Quality Project Management must thrive in a… more
- Terns Pharmaceuticals, Inc. (Foster City, CA)
- Vice President, Regulatory Affairs and Quality AssuranceTerns Pharmaceuticals, Inc. (NASDAQ: TERN) is a clinical-stage biopharmaceutical company developing a ... preclinical GIPR modulator program.Who We Are Looking ForThe Vice President, Regulatory Affairs and Quality Assurance, will lead the regulatory and … more
- Pulmovant (New York, NY)
- …each meticulously tailored to address a specific medical need. Summary The Head of Regulatory Affairs and Quality is responsible for leading the global ... regulatory and quality strategy and support as a member of a...the company's senior management team, managing activities across the regulatory affairs and quality assurance and control… more
- Ironwood Pharmaceuticals (Boston, MA)
- …Lead the Regulatory Affairs-CMC function to prepare and submit high- quality regulatory CMC submissions and oversee all technical writing of ... (CDMOs) and testing labs to ensure the highest integrity in regulatory and quality compliance. Engage with global health authorities to gain alignment on… more
- AstraZeneca GmbH (Boston, MA)
- …and renewals for commercial products.Define and lead the development of high quality regulatory submissions.Manage, track, and assure accountability to global ... with Health Authorities in order to discuss and define regulatory applications ( Quality Module, Responses, and Commitments). May act as CMC representative… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- …groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities and will have frequent interaction ... is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned products have a successful … more
- Avidity Biosciences, Inc. (San Diego, CA)
- …oligonucleotides strongly preferred.Demonstrated evidence of writing CMC portions of high- quality regulatory documents.Strong eCTD knowledge and regulatory ... Job Title:Associate Director, Regulatory AffairsLocation:San Diego, CA / Hybrid / RemotePosition type:Full timeFLSA:ExemptDepartment: Regulatory and QualityStrive… more
- PSG Global Solutions (Cambridge, MA)
- …company goals.Leads preparation, including driving strategy and content of high quality regulatory submission content focusing on chemistry, manufacturing, and ... DescriptionWe're looking for an Associate Director Regulatory Affairs CMC, working in the Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts,… more
- Invivyd (Boston, MA)
- …making a difference. Be part of Invivyd. Position: Senior Vice President Regulatory Affairs and Quality Assurance Responsibilities: Provides high-level strategic ... Agency Interactions. Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality , and Medical Writing departments, leading… more
- Friends (Boston, MA)
- …products, ensuring seamless coordination, timely delivery, and adherence to quality standards.Provides proactive leadership, strategic regulatory guidance, and ... regional Regulatory Heads, overseas and directs the creation of high quality , complaint regulatory labeling documents.Ensures program teams, regulatory … more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …at ORIC. This involves working closely with cross-functional colleagues including regulatory operations, quality , CMC, nonclinical and clinical team members. ... for all ORIC's development programs. Lead to deliver high quality and timely regulatory submissions in alignment with corporate goals, and in compliance… more
- Takeda Pharmaceutical (Boston, MA)
- …products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Provides proactive leadership, strategic regulatory guidance, ... Heads, overseas and directs the creation of high quality , compliant regulatory labeling documents. Ensures program teams, regulatory colleagues,… more
- Dennis Partners (San Francisco, CA)
- …to regulatory agencies to achieve development goals. Ensure on-time, high- quality and regulatory -compliant submissions.Provide strategic direction to all ... of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA… more
- BridgeBio Pharma (San Francisco, CA)
- …and support for product development and registration strategies, including broad regulatory oversight for program developmentEnsure high- quality and timely ... Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.The VP, Regulatory Affairs will provide strategic regulatory expertise to support the… more
- State Street (Boston, MA)
- …in preparation for successful interactions with regulatorsTracking and reporting on interaction quality and cadence, regulatory themes and focus areas across ... themes and focusProviding oversight and guidance on the quality and sufficiency of regulatory responses and...guidance on the quality and sufficiency of regulatory responses and ensuring adherence to enterprise-wide requirements Education… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Science, collaborates with product development, manufacturing and quality teams on the construction, documentation and defense of the analytical ... time approval of regulatory control strategies.Evaluates and implements new regulatory and quality requirements for analytical control strategy in… more
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