Remote Director, Regulatory Affairs — FDA Strategy & Submissions
Stryker Orthopaedics
- Remote job
Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive experience in regulatory roles and the ability to negotiate with various stakeholders. The ideal candidate will possess strong leadership skills, a relevant bachelor’s degree, and a demonstrated ability to develop effective regulatory strategies. Benefits include medical and dental insurance, vacation days, and a robust 401K plan. #J-18808-Ljbffr Stryker Corporation
$110k - $150k
...we are building a regulatory team that will adopt... ...authorization from FDA. Our Manager of Regulatory Affairs will work closely with... ...global regulatory strategies to support business... ...and assisting with submissions and correspondence... ...testing plans #LI-remote$110,000-$150,000The...Remote workFull time$226.5k - $317.1k
About the RoleThe Senior Director Regulatory Affairs Strategy will play a key role in guiding... ...depth understanding of US FDA and international... ...execution of major regulatory submissions (US and global), global submission... ...hybrid work environment; remote work may be considered.We...Remote workWork at officeLocal area$169.5k - $248.6k
...RoleAs the Global Regulatory Lead (GRL), you will... ...global regulatory strategies— from portfolio... ...strategy with the US FDA.Key... ...OversightOversee all US FDA submissions and agency interactions... ...in regulatory affairs and/or drug developmentORBachelor... ...is provided, remote is not available...Remote workLocal areaRelocationFlexible hours$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing... ...authorities, including the FDA, EMA, and other regulatory... ...requirements. Regulatory Submissions Oversee the preparation...Remote workTemporary workLocal areaWeekend work- ...est. Location: REMOTE EST Salary: MarketJob... .../ Position:Director/Senior Director Regulatory AffairsDepartment... ...Director of Regulatory Affairs will report to... ...regulatory strategies that support efficient... ..., review, and submission of regulatory... ...with FDA, EMA, MHRA and other...Remote work
$116k - $151k
...Summary:The Manager, Regulatory Affairs provides regulatory leadership... ...of global regulatory strategies from development... ...regulatory planning, submission execution, Health... ...Working knowledge of FDA, EMA, ICH, and other... ...expected to be 100% remote.Total Rewards Offerings...Remote workFull timeContract workTemporary work$177k - $278.08k
...worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be... ...Labeling Documents Authoring, Submission, and Labeling Negotiations... ..., safety, medical affairs, and commercial, to ensure... ...currently classified as "remote" in accordance with Takeda...Remote workMinimum wageTemporary workLocal areaWorldwide$183.55k - $275.32k
...Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory... ..., including FDA requirements. This... ...accurate FDA 2253 submissions of US promotional... ...experience in Regulatory Affairs within the... ...ability to be either remote in the US or hybrid...Remote workTemporary workLocal areaWork from homeFlexible hours3 days per week$200k - $250k
...Senior Director, Regulatory Strategy Consulting 4 days ago – Be among... ...President, Regulatory Affairs, the Senior Director... .... Work Location: Remote position. Travel may... ...major global regulatory submissions (INDs, CTAs, NDAs,... ...client in meetings with FDA and global health...Remote workFull time- ...dialysis care setting. The Regulatory Affairs Director is responsible for... ...overall regulatory strategy during product... ...prepares regulatory submissions for new products and... ...to, the following: US FDA Investigational Device... ...‑station environment Remote work environment is also...Remote workWork at officeLocal area
$165k - $185k
...Senior Manager Regulatory Strategy Requisition ID: 7813 Location... ...journey of growth! Remote/Commuter Opportunity -... ...intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages,... ...perspective at Regulatory Affairs Focus Team (RAFT)...Remote workWork at officeFlexible hours- ...looking for diverse, talented people to join Alcon. As a Director, Regulatory Affairs Strategy (Management Path) supporting Alcon’s Quality &... ...lifecycle, preparing and overseeing high‑quality regulatory submissions, and serving as the primary liaison with global health...Full timeTemporary workLocal areaRelocationFlexible hours
$205k - $341.6k
...serious diseases. We are seeking a Director to join our Regulatory Affairs Strategy team.The Director, Regulatory... ...support and will lead IND/CTA and BLA submission activities.The Director will develop... ...a strong understanding of US FDA and international pharmaceutical guidance...Full timeWorldwideRelocation package$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston... ..., from current stage through BLA submission, ensuring an efficient route to... ...Skills/Experience: Experience with FDA advisory committee and/or EMA oral explanation...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role: Are you ready to steer global... ...interactions through major submissions and post-approval maintenance—helping... ...submission activity. Experience with FDA advisory committee or EMA oral explanation...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week$134.6k - $230.8k
...0/yearJob Area: Regulatory & ComplianceCompany... ...together. The Director of Regulatory Affairs will be a member... ...plans/strategies as required.You'... ...flexibility to work remotely * from anywhere... ...support regulatory submissions and filings as neededDevelop... ...filings to the FDA, EU MDR, and/or...Remote workMinimum wageFull timeWork experience placementWork at officeLocal area$177k - $278.08k
...to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is... ...innovative global regulatory strategies and providing strategic regulatory... .... Accountable for all US FDA submissions and approvals of project(... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workMinimum wageTemporary workLocal areaWorldwide$177k - $278.08k
...role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...the regulatory CMC strategy and leads the execution of... ...aspects of global registrational submissions of complex drug product or... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA...Remote workMinimum wageTemporary workLocal areaWorldwide$148.5k - $257.4k
...strategic, tactical and operational regulatory CMC leadership across... ..., and post approval submissions. This is accomplished through... ...implementation of innovative regulatory strategies and platform approaches... ...: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRelocation packageFlexible hours$240k - $275k
...Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide... ...global regulatory strategy for one or more... ...(CTR) and CTA submissions.Serve as the primary... ...(e.g., FDA, EMA, Health Canada... ...San Diego office. Remote permitted upon approval...Remote workFull timeSummer workWork at officeRelocationRelocation packageShift work- ...includes the first and only FDA‑approved treatments... ...The Associate Director, Regulatory Affairs Project Planning & Coordination... ...executes regulatory strategy. This role will also... ...of regulatory submission timelines, compliance... ...working independently from remote locations. The...Remote workWork at officeLocal areaNight shift3 days per week
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ..., define target product labeling, and accelerate submissions across multiple indications and modalities. As a senior...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week- ...DescriptionGeneral Summary:The Regulatory Labeling Director will lead the... ..., CA).Lead labeling strategy with expert ability... ...authorities, including the FDA, EMA, and may include... ...in regulatory affairs in the area of global... ...more.Flex Designation:Remote-EligibleFlex Eligibility...Remote workFull timeSummer workWork at officeLocal areaFlexible hours2 days per week
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert... ...including for regulatory submission documents and Health... ...status of global Regulatory Affairs strategies and tactics,... ...designated as: 1. Hybrid: work remotely up to two days per week;...Remote workFull timeSummer workWork at officeLocal areaFlexible hours2 days per week3 days per week$180k - $245k
...experienced and strategic Director of Regulatory Affairs to lead and support global... ...and executing regulatory strategies that support global product... ...expectations.Lead the preparation, submission, and maintenance of... ...authorities, including FDA, EMA, and other major agencies...- ...biopharmaceutical company seeking a Senior Director, US Regional Regulatory Lead to shape US regulatory strategy and lead FDA interactions. You will drive... ...12+ years in Regulatory Affairs, leadership experience, and... .... Hybrid in Boston or 100% Remote on the US East Coast, some...Remote work
- ...UT MD Anderson seeks a Director of Clinical Research Regulatory Affairs to oversee regulatory activities for FDA submissions across oncology trials, INDs, IDEs, and devices. Strong... ...knowledge, and RAC certification are preferred. Remote work option available in a fast-paced...Remote work
- ...Pharmaceuticals is seeking a Director, Regulatory Affairs for Infectious Diseases to lead global regulatory strategy from early development... ...stages. The role oversees submissions, agency interactions, and cross... ...Regulatory Affairs and can be remote or based in a Tonix office....Remote workWork at office
- ...Therapeutics seeks an Executive Director of Regulatory Affairs to lead global regulatory strategy for our autoimmune cell... ...Market Access, and Legal to ensure submission readiness and lifecycle management... ...high-performing regulatory team. Remote role (West Coast hours...Remote work
$207.5k - $255.2k
...clinic. We are seeking a Director of Regulatory Affairs who will play a... ...supporting global regulatory strategy, overseeing... ...applications, pediatric submissions, etc.). Create,... ...Health Authority (US FDA, Health Canada, UK MHRA... ...: This role is remote‑friendly, with most...Remote workOdd jobWork at officeLocal areaImmediate startWork from home
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