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$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- ...is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development... ...conversion to permanent roles. Remote work is supported during...Remote jobPermanent employmentContract work
- ...company focused on MASH and liver fibrosis is seeking a (Senior) Director, Regulatory Affairs. In this remote role, you will lead U.S. regulatory strategy, particularly for FDA engagement and regulatory submission mechanics. The ideal candidate should have 8+ years of...Remote job
- ...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
- ...Brown & Brown is seeking a Senior Director of Regulatory & Legislative Strategy - Public Sector to join our growing... ...Prohibition Attestations, RxDC submissions, and TiC updates in coordination with... ...The Power to Be Yourself”. SummaryLocation: Remote - FloridaType: Full timeRemote workFull time
$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$165k - $185k
...our journey of growth! Remote/Commuter Opportunity -... ...The Senior Manager, Regulatory Strategy (US RA): supports the creation... ...for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews... ...at Regulatory Affairs Focus Team (RAFT) meetings...Remote workWork at officeFlexible hours$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...- ...Sciences is looking for a Regulatory Director in South San Francisco to develop... ...innovative regulatory strategies, ensuring compliance with health... ..., overseeing regulatory submissions, and guiding development... ...experience, and knowledge of FDA and EMA regulations. The...
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and... ...This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...
- AskBio Inc., a Bayer subsidiary, seeks a senior Regulatory Affairs leader to drive global regulatory strategies for gene therapy programs. The role focuses on preclinical... ...ROW. The position involves leading regulatory submissions, agency interactions, and development-stage...Remote job
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
- A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory... ...US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in a relevant...Contract work
- ...biotechnology company in Seattle is seeking a Director/Sr. Director for Regulatory Affairs focused on CMC. This role involves developing strategies, managing interactions with regulatory agencies, and ensuring compliance with submission standards. Ideal candidates will have 7...
- Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to provide regulatory support for marketed products and development programs... ...include preparing INDs and NDAs, managing submissions to FDA and other health authorities, maintaining #J-18808-Ljbffr...
$189k - $246k
Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute comprehensive regulatory strategies supporting clinical... ...with cross-functional teams and leading regulatory submissions for pivotal trial designs and marketing applications....Remote job- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for Phase... ...in leading strategies for regulatory submissions and interactions with authorities like the FDA. Comprehensive benefits including health and...Remote job
- Travere Therapeutics seeks a Director of Regulatory Affairs to develop and execute global regulatory strategies for Phase 2 and Phase 3 clinical development. The ideal candidate... .... The role involves leading regulatory submissions, collaborating with various departments,...Remote job
$200k - $235k
...journey of growth! Remote/Commuter Opportunity - Open... ...United States The Director, US Regulatory Affairs Strategy, oversees the implementation... ...packages for the US FDA. Liaises with FDA as needed... ...participation in submissions to ex-US authorities....Remote workWork at officeFlexible hours$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,... ...in meetings with FDA and global health authorities...Remote workFull time$210k - $235k
...development, commercial strategy, and beyond.... ...and geographies. The Director, Regulatory Strategy provides global... ...sequencing of regulatory submissions. Anticipate and... ...experience in Regulatory Affairs within the... ...regulatory authorities . Remote role; occasional travel...Remote workWorldwideFlexible hours- Exelixis Inc in Alameda, CA is seeking a Regulatory Affairs leader to develop and implement global regulatory strategies that align with asset and corporate goals and health... ...of organized, scientifically valid submissions and communicate regulatory plans to stakeholders...
- ...based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical execution... ...coordinating with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years in drug development...
- ...biopharmaceutical company, seeks an Associate Director of Regulatory Affairs to lead regulatory activities across... ...interact with health authorities. You will drive strategies for assigned programs, prepare high-quality submissions, and guide cross-functional teams to ensure...
$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$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$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
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