Regulatory Documentation Coordinator

Job SummarySarepta Therapeutics is seeking a highly experienced Regulatory Strategy Director to lead our regulatory affairs efforts. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that ensure compliance with global regulations and facilitate the approval of our therapeutic programs.Key...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who will guide drug development initiatives by leveraging extensive expertise to inform project teams on regulatory standards,...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader for various regulatory projects at different stages of development. This position requires a strategic mindset to guide drug development initiatives and ensure adherence to regulatory standards.Key Responsibilities:Oversees the...

About the RoleModerna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in developing and implementing regulatory strategies for our mRNA therapeutics.Key ResponsibilitiesDevelop and contribute to content, format,...

The Role:The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who can effectively guide drug development initiatives by leveraging extensive expertise in regulatory frameworks.Key...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory expert who will guide drug development initiatives, leveraging extensive expertise to inform project teams on compliance requirements and...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader in regulatory projects across various development phases. This position is essential for guiding drug development initiatives and leveraging extensive regulatory knowledge to support project teams in navigating complex...

**This position requires 3 days onsite in Cambridge**The role acts as a liaison with Health Authorities and serves as the Regulatory Project Leader for various initiatives at different stages of development. Responsibilities include:Strategic LeadershipProvides expert regulatory guidance for assigned drug development projects, leveraging extensive knowledge...

Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRESVIA, Modernas late stage / marketed RSV messenger RNA (mRNA) vaccine (Adult indication) to be based in one of Modernas East Coast hubs. The Global Regulatory Lead (GRL) role is intended for a forward looking, creative regulatory strategist able to...

About the RoleWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs and Compliance team at Apnimed. As a key member of our leadership team, you will play a critical role in advancing our innovative sleep apnea treatments through clinical trials and commercialization globally.Key ResponsibilitiesRegulatory Strategy and Planning:...

Job SummaryWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs and Compliance team at Apnimed. As a key member of our leadership team, you will be responsible for developing and executing regulatory strategies to support the approval and commercialization of our therapies globally.Key ResponsibilitiesRegulatory Strategy and...

Position OverviewKytopen is at the forefront of enhancing cell engineering for advanced cell therapies, aiming to broaden access to innovative living medicines. Our unique continuous Flowfect non-viral transfection platform is designed to deliver rapid, scalable, and gentle processes that produce billions of high-quality engineered cells in mere minutes...

The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy for the COVID-19 franchise to be based in its Cambridge headquarters or one of Modernas East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market...

Job Summary:Proclinical Staffing is seeking a highly experienced Director, Global Regulatory Labeling to join our team. As a key member of our organization, you will be responsible for developing and executing regulatory labeling strategies for our global biotech clients.Key Responsibilities:Regulatory Labeling Strategy: Develop and maintain current...

Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory...

The Role:Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise to be based in one of Modernas US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology...

Job Title: Regulatory Affairs Senior SpecialistJob Description:In light of the pressing challenges our world faces today, the mission of Philips has never been more significant. If you share our commitment to enhancing lives, your contributions will be pivotal in shaping a more equitable future for everyone.In this position, you will have the opportunity...