CMC Submissions Lead

Job Title: CMC Submissions LeadTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA. As a key member of our regulatory affairs team, you will be responsible for creating and maintaining regulatory submission content plans, timelines, and submission strategies for CMC Module 3 information.Key...

Job Title: CMC Submissions LeadTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA.Job Summary:We are looking for a seasoned professional with expertise in global regulatory guidelines, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements for New...

Job Title: CMC Expert - BiologicsLocation: Hybrid (NJ, Boston)Job Description:We are seeking a highly skilled CMC Expert specializing in Biologics to provide regulatory and lifecycle management support for a large client. This role is instrumental in fulfilling client needs for regulatory submissions, ensuring compliance with post-approval processes, and...

About the RoleTakeda Pharmaceuticals is seeking a highly experienced Senior Director to lead our CMC Pharmaceutical Development Portfolio. As a key member of our Regulatory Affairs team, you will be responsible for establishing collaboration with Global CMC teams and leadership, enabling CMC regulatory team's success in meeting goals and objectives.Key...

About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.We are seeking a highly experienced Director, Regulatory Affairs CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration...

About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.We are seeking a highly experienced Senior Director to lead our GRA CMC Pharmaceuticals Development Portfolio team.Key Responsibilities:Establish collaboration with Global...

Job DescriptionThe Chemistry Manufacturing Controls Associate Director plays a pivotal role in executing global regulatory CMC strategies for investigational and marketed products. This position leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. Additionally, this role provides...

Job DescriptionTakeda Pharmaceutical is seeking a highly skilled Senior Director and Regulatory Platform Lead to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key Responsibilities:Develop and...

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 Title: Associate Director, Chemistry Manufacturing ControlsJob Summary:The Associate Director, Chemistry Manufacturing Controls, plays a critical role in executing global regulatory CMC strategies for investigational and marketed products. This position leads the preparation and filing of regulatory CMC submissions and manages interactions with Health...

Job DescriptionTakeda Pharmaceutical is seeking a highly skilled Technical Regulatory Advisor GRA CMC, Drug-Device Combinations US to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative device and integral/co-packaged combination product regulatory strategies for development, registration,...

About the Role:Takeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a highly skilled Manager, Global Regulatory Affairs CMC Submission Management to support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned...

Job DescriptionWe are seeking a highly experienced Senior Director to lead our Regulatory Platform for CMC and Device-Drug Combinations. As a key member of our team, you will be responsible for developing and implementing innovative regulatory strategies to ensure the successful launch of our products.Key Responsibilities:Develop and implement regulatory...

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...

Job Title: Senior Director/Executive Director CMCAbout the Role:At AL Solutions, we are seeking a highly experienced Senior Director/Executive Director CMC to lead our CMC teams in the development and optimization of protein biologics processes. This is a unique opportunity to utilize your CMC expertise to steer the nomination of Development Candidates and...

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 SummaryAbbVie is seeking a highly experienced and skilled professional to lead our global technical support for a commercial biotherapeutic product. As a key member of our CMC Sciences team, you will be responsible for supporting global regulatory submissions, developing strategies for successful product launches, and driving process improvements and...

Job DescriptionAt Takeda Pharmaceutical, we are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status,...

Job Title: Director of Cell and Molecular BiologyVerve Therapeutics, Inc. is seeking a highly skilled Director of Cell and Molecular Biology to join its Analytical Development-CMC team. The successful candidate will be responsible for leading the development and qualification of analytical methods for mRNA and gRNA oligonucleotide drug substance and drug...

Job Title: Drug Discovery LeadWe are seeking a highly skilled and experienced Drug Discovery Lead to join our Oncology Drug Discovery Unit at Takeda Pharmaceutical. As a key member of our team, you will be responsible for leading the discovery and development of innovative cancer therapies.Key Responsibilities:Lead and manage multiple drug discovery projects...