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Xilio Therapeutics
Watertown, MA, United States
Vice President, Regulatory Affairs and Quality Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its
Job Source: Xilio TherapeuticsXilio Therapeutics
Waltham, MA, United States
Vice President, Regulatory Affairs and Quality Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its
Job Source: Xilio TherapeuticsXilio Therapeutics
Watertown, MA, United States
Vice President, Regulatory Affairs and Quality Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its
Job Source: Xilio TherapeuticsConfidential
Newton, MA, United States
Vice President, Regulatory Affairs About the Company Innovative biotechnology company specializing in Alzheimer's disease therapeutics & diagnostics Industry Biotechnology Type Public Company Founded 1996 Employees 51-200 Categories Biotechnology Pharmaceuticals Academic Research Health Care Medical Care Medical Conditions Therapeutics Medical Dia
Job Source: ConfidentialHays Recruitment
Boston, MA, United States
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Job Source: Hays RecruitmentConfidential
Boston, MA, United States
Vice President Regulatory Affairs About the Company Revolutionary biotechnology company Industry Biotechnology Type Privately Held About the Role The Company is seeking a Vice President of Regulatory Affairs to play a pivotal role in ensuring the regulatory compliance and driving strategic initiatives for their innovative, life-saving blood produ
Job Source: ConfidentialConfidential
Boston, MA, United States
Vice President Regulatory Affairs About the Company Globally recognized telecommunications & technology company Industry Telecommunications Type Public Company Founded 1865 Employees 10,001+ Categories Information Technology & Services Networking Technology Telecommunications Hardware Telecom Hardware Telephones Wireless Phones Specialties Telec
Job Source: ConfidentialDennis Partners
Boston, MA, United States
This clinical-stage biotech company is developing innovative treatments for multiple neurodegenerative diseases. They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead both functions, and serve as the primary contact with FDA. Reporting into the CMO, you will provide crucial input on all regulatory matters related to t
Job Source: Dennis PartnersWaltham, MA, United States
Vice President, Regulatory Affairs & Quality
About the Company
Innovative biopharmaceutical company developing tumor-selective immunotherapies
Industry
Pharmaceuticals
Type
Privately Held
Founded
2016
Employees
51-200
Categories
Pharmaceuticals
Medicine
Manufacturing
Chemical Products
Biotechnology
About the Role
The Company is seeking a Vice President of Regulatory Affairs and Quality to lead the design and execution of global registration strategies for its innovative immuno-oncology therapies. The successful candidate will be responsible for all regulatory activities, ensuring compliance with local and regional GxP requirements, and aligning with the company's policies. This role demands a professional with a strategic mindset, extensive experience in biotechnology and pharmaceuticals, and a strong background in regulatory strategy, particularly in the field of oncology development. The VP will also oversee the development and implementation of CMC regulatory strategies, anticipate and manage risks, and stay abreast of regulatory and access environment trends to strengthen product development plans.Applicants for the Vice President position must have a BS in a scientific or engineering discipline, with an advanced degree preferred, and at least 15 years' of experience in the industry. A minimum of 10 years' in regulatory strategy, including experience as a primary regulatory author for IND and CTA documents, is required. The role involves not only regulatory leadership but also a significant quality management component, with accountability for ensuring GMP, GLP, and GCP compliance. The ideal candidate will be a strong leader, capable of managing a budget, and will have a proven track record of fostering a culture of equity, diversity, and inclusion. Strong communication skills, the ability to interpret scientific data for regulatory purposes, and a commitment to upholding the values of the company are essential.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions
Medical Care/Hospital Administration
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Email Alert for Vice President, Regulatory Affairs & Quality jobs in Waltham, MA, United States
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