Facilities Regulatory Affairs Strategic Lead

As a key member of project teams at ONO PHARMA USA, the Associate Director, Regulatory Affairs will serve as a Health Authority liaison and establish regulatory strategies for development programs. This role is responsible for coordinating timelines, generating, and submitting complex regulatory dossiers.Key ResponsibilitiesManages the planning, preparation,...

Job SummaryThe Senior Director, US Commercial Regulatory Affairs is responsible for leading the team involved in post-marketing regulatory activities to support Ipsen's marketed products in the US. This includes prior approval submissions to FDA Office of Prescription Drug Promotion (OPDP) as required, working with Global Regulatory Labeling to review and...

About the RoleThe Director for U.S. Advertising and Promotion will provide strategic regulatory guidance to internal stakeholders on communications related to Alnylam's marketed products, investigational treatments, and disease areas. This role will enable achievement of business objectives while ensuring compliance with U.S. laws and regulations and Alnylam...

Job SummaryAs a Regulatory Affairs Director at Ipsen Pharma, you will be responsible for developing and implementing regulatory strategies for assigned programs and products. You will provide regulatory expertise to R&D, Franchise, and Commercial Operations, and act as the interface between these teams and global regulatory authorities. Your goal will be to...

Company Overview:Beam Therapeutics is a pioneering biotechnology company dedicated to developing innovative genetic medicines. Our mission is to revolutionize the treatment of serious diseases by harnessing the power of precision genetic editing.We are committed to a values-driven approach, prioritizing cutting-edge science, and a vision of providing...

This is a highly challenging opportunity to lead a team in a fast-paced environment at ICON Strategic Solutions, a leading global provider of outsourced development services. The primary role of the Director, IVD Design Control and Project Management, is to oversee the scientific aspects of assay development/validation projects to meet regulatory...

Job Title: Senior Regulatory Affairs Specialist, OperationsAbout the Role:The Senior Regulatory Affairs Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.This role will primarily support Software as a Medical Device (SaMD) and may include support for ventilators, oxygenators, and...

Job SummaryThe Senior Director, US Commercial Regulatory Affairs will lead the development and implementation of regulatory strategies to support Ipsen's commercial operations in the US. This role will be responsible for ensuring compliance with FDA regulations and guidelines, as well as maintaining strong relationships with key stakeholders.Key...

Clinical Affairs Consultant Role OverviewThe Clinical Affairs Consultant role is a key position within our organization, responsible for leading the development of evidence generation strategies for assigned projects. This involves working closely with internal and external stakeholders to ensure that studies yield well-founded conclusions.Key...

About the RoleAxim Collaborative, Inc. is seeking a seasoned professional to serve as the Vice President, Partnerships and External Affairs. This key leadership position will be responsible for developing high-level strategic partnerships and overseeing the organization's marketing and communications efforts.Key ResponsibilitiesCurate and manage a portfolio...

Job Summary:Senior Manager, Membership, J-WEL, is responsible for providing strategic vision and oversight for all membership-related activities at J-WEL. This includes leading membership development, managing membership tracking and billing, and developing targeted member recruitment models. The ideal candidate will have a bachelor's degree in a related...

Job Title: Medical Director - Neuroscience/PsychiatryAbbVie is seeking a highly skilled Medical Director to lead our Neuroscience/Psychiatry team. As a key member of our Medical Affairs department, you will be responsible for providing strategic medical input into core brand strategies and supporting medical/marketing activities.Key Responsibilities:Provides...

About the RoleWe are seeking a highly skilled and experienced Associate Director, Global Medical Communications, GMA Congress Excellence to join our team at BioSpace, Inc. This is a unique opportunity to lead the development, operationalization, and execution of our scientific and medical congress strategy.Key ResponsibilitiesDevelop and manage the annual...

Job SummaryThe Senior Medical Director, Global Medical Affairs, Lupus will be a strategic partner providing expert medical leadership to guide development, launch planning, and support for dapirolizumab pegol to improve meaningful patient outcomes.Key ResponsibilitiesBuild and maintain external relationships among medical experts globally and be accountable...

Job Title: Global Program ManagerLocation: Cambridge, MA 02142Duration: 04 MonthsDescription:About the role:LanceSoft, Inc. is seeking a Strategic Initiatives Lead to coordinate the Indirect Procurement strategic projects by partnering across the various Procurement teams, Procurement Center of Excellence (CoE), relevant corporate function leaders, and the...

About the Role:Takeda is seeking a highly skilled and experienced Medical Director to lead our Dermatology, US Medical Affairs team. As a key member of our US Medical Affairs organization, you will be responsible for developing and executing medical strategies for our dermatology products, working closely with cross-functional teams to drive business growth...

Job Summary:SENIOR MANAGER, MEMBERSHIP, JAMEEL WORLD EDUCATION LAB (J-WEL), Open Learning, JWEL, provides strategic vision, oversight, and management for all activities of J-WEL that relate to members and J-WEL's overall membership model; leads membership development; which may include fostering the early stage development of projects; recruits new members,...

About the Role:The Associate Director, Global Publications, mature brands, is a key strategic partner of the mature brands Medical Affairs team who develops, prioritizes, and implements the strategic global publication planning for the assigned programs.This role works in close collaboration with key stakeholders in MPD, MCE, Region/LOCs, global medical...

Job DetailsThe Role:As a key member of our Global Regulatory Science team, we are seeking a Director of Global Regulatory Strategy to develop and lead the global strategy for our mRNA vaccine programs. The ideal candidate will have a strong background in regulatory strategy, particularly in vaccine development, and will be able to articulate clear and...

Regulatory Labeling DirectorWe are seeking a highly skilled Regulatory Labeling Director to join our team at BioSpace, Inc. This is a unique opportunity to leverage your expertise in regulatory labeling to drive the success of our respiratory franchise products.Key Responsibilities:Develop and maintain current knowledge of labeling regulations and industry...