Regulatory CMC Director or Associate Director

Define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. Provide strategic and operational support for small molecule pipeline. Represent regulatory-CMC on cross-functional project and technical teams. Develop regulatory-CMC strategies based on regulatory and technical experience,...

Scismic is supporting the growth of a Boston-based biotechnology company that is discovering and developing novel medicines for cancer. We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first in role and will report directly to the Head of Development Operations. This individual will provide...

Scismic is supporting the growth of a Boston-based biotechnology company that is discovering and developing novel medicines for cancer. We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first in role and will report directly to the Head of Development Operations. This individual will provide...

Summary: The Senior Director, CMC Operations (Technical Operations) position is a key leadership role responsible for planning and execution of development, manufacturing, and supply chain activities. The Senior Director, CMC Operations is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer....

Define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. Provide strategic and operational support for small molecule pipeline.Represent regulatory-CMC on cross-functional project and technical teams.Develop regulatory-CMC strategies based on regulatory and technical experience,...

Director, CMC Bioconjugation & External Manufacturing With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular...

Consultant Regulatory CMC- Permanent - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA.Primary Responsibilities:The successful candidate will provide lifecycle management support to a broad, global...

Job Summary: We are looking for an experienced Associate Director/Director, Global Program Manager to join our growing team. This successful candidate will partner with team leaders to develop and execute strategies and operational plans to advance projects through Development. They will identify project risks, develop mitigation approaches, and manage...

Job#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location:  Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...

Job Summary: We are looking for an experienced Associate Director/Director, Global Program Manager to join our growing team. This successful candidate will partner with team leaders to develop and execute strategies and operational plans to advance projects through Development. They will identify project risks, develop mitigation approaches, and manage...

Consultant Regulatory CMC- Permanent Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in...

ESSENTIAL JOB FUNCTIONS: The Associate Director/Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to...

Senior Director, Regulatory Project & Submission Management Opportunities for Senior Director, Regulatory Project & Submission Management in Boston, MA Remote positions only Search completed. Found 0 matching records. Opportunities for Senior Director, Regulatory Project & Submission Management in Boston, MA Remote positions only Search...

As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a...

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million...

Director, Regulatory Strategist – Global Regulatory Lead (Hybrid) Reporting into the VP Head of Regulatory, you will be responsible for the global regulatory strategic development for one of our lead assets, providing a unique opportunity for a motivated and team-orientated individual who flourishes in an environment where they can help lead and shape...

Director Analytical Development A Stealth Mode Third Rock Ventures Start Up is looking for a Analytical Development Leader to join our growing CMC team. The Director maintains a broad knowledge of established, emerging and highly innovative analytical tools and technologies. This role will utilize internal and external networks, and prior relevant...

Summary: The Senior Director, Drug Product (Technical Operations) position is a key leadership role responsible for antibody drug product development and manufacturing. The Senior Director, Drug Product is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer. This role provides the opportunity to...

Director, Bioprocess Development Boston, MA Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...

About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...