Associate Director, CMC Compliance Specialist

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...

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 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...

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 OverviewVertex is seeking a highly skilled Associate Director of Chemistry Manufacturing Controls to execute global regulatory CMC strategies for investigational and marketed products. This role will lead the preparation and filing of regulatory CMC submissions, manage interactions with Health Authorities, and provide regulatory guidance to...

About the RoleAt Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...

Job DescriptionTakeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in a full-time capacity. As a key member of our regulatory affairs team, you will be responsible for ensuring the timely and accurate submission of CMC Module 3 information to regulatory authorities.Key Responsibilities:Develop and maintain a...

Compliance Director Job DescriptionBoston University's Compliance Services Office (CSO) is seeking a highly motivated and collaborative compliance professional to join its University-wide compliance office.The Compliance Director will provide critical leadership, development, implementation, facilitation, and coordination of Boston University's Compliance...

Compliance Director Job DescriptionBoston University's Compliance Services Office (CSO) is seeking a highly motivated and collaborative compliance professional to join its University-wide compliance office.The Compliance Director will provide critical leadership, development, implementation, facilitation, and coordination of Boston University's Compliance...

The Compliance Associate RoleAt Cambridge Associates LLC, we are seeking a highly skilled Compliance Associate to join our team. As a key member of our compliance department, you will play a critical role in ensuring the firm's compliance with regulatory requirements and industry standards.Key Responsibilities• Develop and implement compliance programs and...

Job Title: Director, FDAS ComplianceAt Fidelity Investments, we are seeking a highly skilled and experienced Director, FDAS Compliance to join our team. As a key member of our Compliance department, you will play a critical role in ensuring that our digital assets business operates in compliance with all relevant regulations and laws.Key...

Job Title: Associate Director, Fund Stewardship and Compliance Boston University is seeking an experienced Associate Director to join our Development and Alumni Relations team. This role will play a critical part in ensuring the effective management of restricted funds, ensuring compliance with donor restrictions, University policy, and industry...

Job Title: Associate Director, Fund Stewardship and Compliance Boston University is seeking an experienced Associate Director to join our Development and Alumni Relations team. This role will play a key part in ensuring the effective management of restricted funds, working closely with academic and financial partners to promote compliance and integrity in...

Job Summary:About the Role:Fidelity Investments is seeking a highly skilled Compliance Director to join our Fidelity Digital Assets team. As a key member of our Compliance team, you will play a critical role in promoting a culture of ethical conduct and commitment to compliance, regulatory, and legal obligations.Key Responsibilities:Lead the Regulatory...

Job Title: Associate Director, Fund Stewardship and ComplianceWe are seeking an experienced Associate Director to join our Stewardship and Donor Relations team at Boston University. The successful candidate will play a key role in refining a comprehensive, donor-centric strategy around fund management, working closely with our Stewardship and Donor...

Job Title: Associate Director, Fund Stewardship and ComplianceWe are seeking an experienced Associate Director to join our Stewardship and Donor Relations team at Boston University. The successful candidate will play a key role in refining our comprehensive, donor-centric strategy around fund management, working closely with our Stewardship and Donor...

About the RoleWe are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and...

Job DescriptionGeneral Position Summary:The GMP Quality Operations Director plays a key role in ensuring the quality of oral solid dosage form products. This position is responsible for providing quality oversight and support to the Vertex Manufacturing Center (VMC) Facility operation in various areas, including manufacturing operations, analytical...

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...

About the RoleWe are seeking a highly skilled Compliance Director to join our team at Fidelity Investments. As a key member of our Compliance team, you will play a critical role in ensuring that our business practices align with regulatory requirements and industry standards.Key Responsibilities:Lead the development and implementation of compliance programs...