management practices, eCTD submissions review, and other tools used within the regulatory group Foster strong relationships... management In-depth knowledge of regulatory submissions, particularly eCTD structure and Modules A thorough working...
will have a strong background in regulatory affairs and experience with IND and BLA submissions. Responsibilities Work with regulatory and CMC...Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions...
Job Title: Associate Director, Regulatory Affairs Regulatory Science & Execution Location: Boston, United States... as US Strategy Lead on assigned programs. Act as submission sub-team lead for US submissions and be a core member of the Regulatory...
partners in review of documentation to support submissions Oversee the development and management of defining key regulatory... supporting development stage programs (Phase 1-4) Proven experience in management and global regulatory submissions (US, LATAM...
an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Tether Evo..., management of breakthrough, TAP, and other available regulatory acceleration programs. Regulatory approval process: Oversee...
and effectively as possible. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the... development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL...
pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas... with Northeastern University, Blueprint Medicines is offering a two-year Regulatory Affairs PharmD fellowship based in Cambridge...
regarding completion of IRB regulatory submissions (e.g., new project applications, activation, amendments, and continuing... regulatory initiatives. Contributes to the development and functioning of the Regulatory Affairs program by identifying issues...
preparation, risk management documents, and reference safety information. Global Regulatory Affairs (Year 2) Assist in the...: The purpose of the Global Patient Safety and Regulatory Affairs (GPS/RA) Fellowship is to provide the fellow with training...
partnership with Northeastern University, BridgeBio is offering a two-year Regulatory Affairs PharmD fellowship based in San... planning, preparation and execution of high-quality regulatory submissions (e.g. Clinical Trial Application (CTA...
partnership with Northeastern University, Alnylam is offering a two-year Regulatory Affairs PharmD fellowship based in Cambridge... other characteristics prohibited by law. Responsibilities: Regulatory Affairs at Alnylam is a global group with diverse scientific...
Associate Regulatory Affairs Director (ARAD), Regulatory Science & Execution will be responsible for supporting strategies... operational activities and execution related to the Regulatory management in the relevant jurisdiction, in support of the...
of what is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs... as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions...
continuity Requirements: Experience in development of Regulatory CMC strategy in support of submissions of clinical trial...Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the...
regulatory filing project management. In-depth conceptual knowledge of types of Global HA submissions and requirements... area. Typically requires 5 years of project management experience in. regulatory/clinical project management or project...
experience in regulatory affairs or in quality management systems relating to medical devices in the EU. Relevant technical... Summary The Senior Manager, Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Combination Products...
global regulatory affairs, global subject matter experts, international LOCs, EU & Canada strategy, Japan and China... (GRT) and, cross-functional subteams and working group to execute regulatory submissions. Assists in the creation...
and drive regulatory CMC submissions, including assembling necessary cross functional teams and timelines relevant to assigned..., PharmD, or PhD preferred. Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND...
at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years...Job Title: Regulatory Strategist Primary Location: Cambridge, MA About the Job Our Global Regulatory Team...
with Regulatory Affairs Lead(s) to plan and prepare global health authority submissions. Manage submission deliverables... Regulatory Affairs team. We want someone who cares about this important work, and who’s driven to connect to our mission...