Regulatory Affairs Fellowship: Global Strategy & Submissions
Northeastern University
Alnylam Pharmaceuticals, in partnership with Northeastern University's Pharmaceutical Industry Fellowships Program, offers a two-year Regulatory Affairs fellowship based in Cambridge, MA. Fellows gain exposure to global regulatory strategy across development programs for RNAi therapies, working with industry partners and Northeastern faculty on professional development and scholarly activities. Responsibilities include assisting with regulatory filings, supporting regulatory strategy, and #J-18808-Ljbffr Northeastern University
- ...company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...This role is vital for supporting ongoing global clinical studies. #J-18808-LjbffrSuggested
- ...University jointly offer a 2-year Regulatory Strategy and Advertising/Promotion/Labeling fellowship based in Cambridge, MA.... ...experience within Global Regulatory Affairs and collaborate with medical... ...preparation for regulatory submissions across US and international...Suggested
$180k - $245k
...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ...expectations.Lead the preparation, submission, and maintenance of regulatory...Suggested$116k - $145k
...clinical and nonclinical regulatory strategic discussions,... ...of regulatory strategy for assigned markets &... ...Acts as the regulatory affairs clinical lead for clinical... ...all regulatory agency submission materials for submissions... ...regulatory support to Global Regulatory Lead in...SuggestedFull timeWork at officeRemote work$200k - $265k
...an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for... ...agreed timelines. Accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving successful...SuggestedFull timeTemporary workWork experience placementWork at officeWorldwide$224.9k - $404.6k
...medicine. Work with exceptional global teams on a broad pipeline... ...leadership for global regulatory strategies supporting select early Oncology... ...oversight of regulatory submissions and interactions, including... ...of progressive Regulatory Affairs experience in the pharmaceutical...Permanent employmentFull timeWork at officeWork from home- ...and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the development and... ...responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory...Full timeWork at officeLocal areaRemote work
$196.7k - $353.4k
...seeking a Sr. Director of Regulatory Strategy to support oncology programs... ...strategic leader within Regulatory Affairs, responsible for developing... ...clear and compelling global regulatory strategies,... ...accountability for regulatory submissions and related supplements and...Permanent employmentFull timeWork at officeWork from home$186.23k - $279.35k
...strategic and operational regulatory leadership to the... ...of current local and global Regulatory trends to identify... ...requirements and strategies. Influence Regulatory... ...and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other...Temporary workWork at officeLocal areaWorldwideFlexible hours3 days per week$177k - $278.08k
...worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the... ....Labeling Documents Authoring, Submission, and Labeling Negotiations Independently... ...clinical, safety, medical affairs, and commercial, to ensure unparalleled...Minimum wageLocal areaRemote workWorldwide- ...Northeastern University, offers a two-year Regulatory Affairs fellowship based in Cambridge, MA. The program develops expertise in global regulatory strategy, with exposure to diverse... ..., gaining experience in regulatory submissions, strategy development, and project...
- ...MA is offering a two-year Regulatory Affairs fellowship in partnership with Northeastern... ...program blends regulatory strategy and advertising/promotion/... .... The Fellow will join Global Regulatory Affairs, gain... ...contribute to regulatory submissions, agency interactions, and...
$154.4k - $242.55k
...Purpose:Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... ...solutions.Accountable for all US FDA submissions and approvals of project(s) of... ...broad concepts within regulatory affairs and implications across the...Minimum wageLocal areaRemote work- Vertex Pharmaceuticals Incorporated is offering a six-month Global Regulatory Affairs - Strategy and Operations Co‑Op in Boston. You will support leadership by organizing operating rhythms, building AI-enabled processes, and maintaining dashboards and reports. This is...
$154.4k - $242.55k
...guidance to teams for the delivery of global regulatory strategies to support development and... ...and execution of required maintenance submissions/notifications to ensure ongoing compliance... ...Effectively represent the Global Regulatory Affairs (GRA) function in senior level...Minimum wageLocal areaRemote work$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ..., registration and/or post-approval strategies for assigned products. RA CMC member... ...development of robust and accurate submissions.Develops constructive relationships...Minimum wageLocal areaRemote workWorldwide- ...critical unmet need. As a global leader in myostatin biology,... ...The Associate Director, Regulatory Strategy, is responsible for the development... ...will represent regulatory affairs at the appropriate program... ...directing the preparation and submission of regulatory submissions...Shift work
$30 - $55 per hour
...Career Launchpad: Build skills, explore career paths, and get guidance for your future career. Your Impact The Vertex Global Regulatory Affairs - Strategy and Operations Co-Op is a 6-month experiential training program for students currently working towards an advanced...Full timeTemporary workSummer workInternshipRemote workFlexible hours2 days per week$171.75k - $286.25k
...Our approach to R&D Position Summary The Director Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory... ...discipline. ~8 years of experience in Regulatory Affairs within the pharmaceutical biotechnology or healthcare industry...Full timeWork at officeLocal area2 days per week3 days per week- ...on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market...Full timeLocal areaWorldwide
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader... ...strategy for the assigned global or regional position and will... ...Documents including for regulatory submission documents and Health... ...status of global Regulatory Affairs strategies and tactics, procedures...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Global Submission Management (GSM) is... ...of a portfolio of global regulatory submissions across... ...alignment with global regulatory strategies and operational objectives.... ...Life Sciences, Regulatory Affairs, Project Management, or a related...Full timeSummer workRemote workFlexible hours2 days per week$60.32k - $85.19k
...University Pharmaceutical Industry Fellowships Program is a two-year... ...Dompé is offering a two-year Global Regulatory Affairs fellowship, based remotely.... ...development and regulatory strategy. Over two years, the fellow will support submission of industry’s regulatory new...Work experience placementH1bRemote workWorldwideVisa sponsorshipWork visa$200.68k - $215.27k
...Cambridge, MAPOSITION: Senior Manager, Global Regulatory Affairs, Marketed ProductsPOSITION... ...vendors to ensure global regulatory submissions are provided to local company affiliates... ...functionally to ensure the global regulatory strategy is updated and executed, ensuring...Minimum wageFull timeWork at officeLocal areaRemote work$266.25k - $384.58k
Job title: Global Head, Regulatory Science — Model-Enabled Development, Real... ...and cutting-edge regulatory strategies across therapeutic areas.... ...regulatory strategies and submissions.Develops and Implements... ...10-15 years of regulatory affairs experience with demonstrated...Full timeWorldwideShift work$177k - $278.08k
...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be... ...Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs.... ...broad concepts within regulatory affairs and implications across the...Minimum wageLocal areaRemote workWorldwide$196.7k - $353.4k
...seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy... ...unprecedented new drug modality globally. The Sr. Director will be a... ...for regulatory submissions and related supplements and... ...overall plans to Regulatory Affairs the Project Team and senior...Permanent employmentFull timeWork at officeWork from home$268.2k - $402.2k
...Summary:The Executive Director, Regulatory Strategy will serve as a seasoned... ...implementation of innovative global regulatory strategies for... ...authorship and quality of regulatory submission documents and Health... ...status of global Regulatory Affairs strategies and tactics, procedures...Full timeSummer workLocal areaRemote workFlexible hours2 days per week- The Vertex Pharmaceuticals Incorporated Global Regulatory Affairs (GRA) fellowship is a two-year program based in Boston, MA, conducted in partnership... ...University. Fellows will receive training in Regulatory Strategy and Global Labeling and will spend eight months in...
- Northeastern University invites Pharm.D. graduates to join a two-year Global Regulatory Affairs fellowship offered in partnership with Dompé. The program combines hands-on drug development and regulatory strategy with collaboration across Clinical, Safety and CMC teams, while...Remote job
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