Director, Regulatory CMC, Biologics

Job SummaryThe Chemistry Manufacturing Controls Associate Director at Vertex is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. The Associate Director provides...

Job SummaryWe are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics.The ideal candidate will have a strong understanding of cGMP,...

Job OverviewWe are seeking a highly experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. The successful candidate will play a key role in vendor management and act...

Job DescriptionWe are seeking a highly experienced Senior Manager/Associate Director of Quality Operations to provide quality oversight for our biologics commercial programs.The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.Ensure CMO compliance with...

Job Summary:This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. As a key member of the BioSpace, Inc. team, you will play a crucial role in vendor management and act as the subject matter expert for sterile drug products.Key Responsibilities:Oversee the production...

About the Role:Takeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Manager to support the execution of regulatory CMC investigational, registration, and post-approval tasks for assigned products. As a key member of the Regulatory Affairs CMC team, you will work closely with cross-functional teams to develop project plans for global...

The Director of Quality Management at KMR Search Group is responsible for overseeing the development, implementation, and evaluation of a quality management system that supports clinical development and regulatory approval of products.This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project...

Job Description:Takeda Pharmaceuticals is seeking a highly skilled Senior Director, Cell Therapy CMC Program Lead to join our team in Cambridge, MA. The ideal candidate will have a Master's degree in Biotechnology, Biomedical Engineering, or a related field, along with 5 years of experience in cell and gene therapy development.Key Responsibilities:Develop,...

Job DescriptionDirector Process Development CMCWe are currently partnered with an innovative Cell Therapy Biotech developing derived immune cell therapy products addressing significant opportunities with unmet clinical needs.As a key member of the CTO's team, you will be responsible for leading and growing a high-performing team and overseeing process...

About Nucleus Biologics:We are a leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization.Our cell culture products and services fuel today's therapies and tomorrow's innovations.We are committed to delivering premium products and services through a transparent,...

About the RoleTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Director of AI Strategy for Biologics Innovation, you will lead the strategic application, integration, and development of machine learning and AI technologies in the discovery and development of...

About the Role:Takeda Pharmaceuticals is seeking a highly skilled Director, Process Optimization, Global Biologics to join our team. As a key member of our Global Biologics organization, you will be responsible for analyzing, designing, and optimizing our lab and business processes to improve efficiency, reduce costs, and enhance overall productivity.You...

Job SummaryTakeda Pharmaceuticals is seeking a highly skilled Medical Director to lead our Biologics Discovery team. As a key member of our organization, you will be responsible for analyzing, designing, and optimizing laboratory processes to improve efficiency, reduce costs, and enhance overall productivity.Key ResponsibilitiesEvaluate current laboratory...

Regulatory Affairs ProfessionalMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to support the global development and approval of our innovative therapies.This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing...

Senior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This position is pivotal in driving regulatory efforts for vaccine development programs. **Primary Responsibilities:** * Manage the full lifecycle of global regulatory submissions and approvals,...

We are seeking a highly skilled Associate Director, CMC Program Lead, Cell Therapies to join our team at Takeda Development Center Americas, Inc. in Cambridge, MA.The ideal candidate will have a Master's degree in Biotechnology, Biomedical Engineering, Bioengineering or a related field, plus 5 years of related experience.Prior experience must...

Job Summary:Fairway Consulting Group is seeking a highly experienced Regulatory Affairs Director to lead our client's global regulatory strategy and execution on development programs. The ideal candidate will have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global...

Job Title: Associate Director, Regulatory Submission ManagementAbout the Role:We are seeking an experienced Associate Director to lead our Regulatory Submission Management team. As a key member of our Global Regulatory Affairs team, you will be responsible for planning, managing, and tracking regulatory submissions across multiple programs.Key...

Job Description:Director, FDAS Compliance - Regulatory Relationship and Exam ManagementThe RoleAs a member of the Fidelity Digital Asset Services, LLC ('FDAS') Compliance team, you will serve as an informed and trusted business partner, who promotes a culture of ethical conduct and commitment to compliance, regulatory and legal obligations. In this role on...

Job SummaryThe Senior Director, Regulatory Strategy, is a key member of the Vertex Pharmaceuticals team responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs. This role plays a major role in shaping cohesive regulatory strategy across assigned programs and ensuring effective...