Remote Director, Regulatory Affairs — FDA Strategy & Submissions
$130k - $250kCrains Cleveland
- Remote job
Mapp Biopharmaceutical in San Diego is looking for a fully remote Director of Regulatory Affairs. This key role includes ensuring compliance with regulations, developing strategies for product development teams, and coordinating regulatory submissions. The ideal candidate will have extensive experience with FDA interactions and a strong background in regulatory leadership within the pharmaceutical industry, with a salary range of $130,000 to $250,000, depending on experience and qualifications. #J-18808-Ljbffr Crains Cleveland
- 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...Remote job
$169.5k - $248.6k
...Role As the Global Regulatory Lead (GRL), you... ...global regulatory strategies— from portfolio entry... ...with the US FDA. Key Responsibilities... ...Oversee all US FDA submissions and agency interactions... ...in regulatory affairs and/or drug... ...relocation is provided, remote is not available for...Remote workFull timeLocal areaRelocationFlexible hours- ...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
$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$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. Compensation and Benefits...Remote workContract workTemporary work- ...Manufacturing and Controls (CMC) regulatory strategy for development and... ...to prepare submissions and respond to regulatory... ...with U.S. FDA or other global regulatory... ...in global regulatory affairs including communication... ...team collaboration and remote days for focused work...Remote workWork at officeLocal areaWorldwide
- ...IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development. Candidates...Remote job
- HUTCHMED is seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs... ...product team in developing registration strategies for product approvals in both the US... ...leveraging their expertise, manage submissions, and develop timelines in...
$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$189k - $246k
...Director, Regulatory Affairs Strategy Be a part of a global team that is inspired to make... ..., including the FDA, EMA, and other regulatory... ...Oversee the preparation and submission of global regulatory documents... ...role is expected to be 100% remote Total Rewards Offerings...Remote workTemporary workLocal areaWeekend work- ...seek an experienced Regulatory professional to... ...the SVP Regulatory Affairs and Quality Assurance... ...SSF headquarters. Remote US candidates are... ...global regulatory strategies for the... ...manage preparation and submissions (including but not... ...Knowledgeable in ICH, FDA, EMA and WHO regulations...Remote work
$285k - $320k
...What You’ll Do Lead CMC regulatory strategy and execution across... ...high-quality submissions aligned with global regulatory... ...This is a U.S.-based remote role that will... ...Extensive Regulatory Affairs CMC experience within... ...active drug trials and FDA pipelines, there are...Remote workWork at officeFlexible hours- Work at Home Mania is seeking a regulatory affairs professional to manage local regulatory and ethics submissions. This remote role focuses on aligning strategies within the biotechnology sector. The ideal candidate will have experience in regulatory submissions and a...Remote jobLocal areaWork from home
$218.06k - $327.09k
Job Title Senior Director, Regulatory Affairs Strategy - Cell Therapy Locations Gaithersburg, MD Boston, MA South... ..., from current stage through BLA submission, ensuring an efficient route to approval... ...Skills/Experience Experience with FDA advisory committee and/or EMA oral...Hourly payTemporary workFlexible hours- ...Redwood City, is searching for a Director Global Regulatory Lead to manage regulatory strategies for product development. The... ...years of comprehensive regulatory affairs experience across major regions... ...include leading regulatory submissions and developing strategic plans....
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco,... ...for leading regulatory strategies for drug approvals and submissions. Candidates should have... ...in Regulatory Affairs CMC within the biotech or... ...position is hybrid, with remote work and occasional onsite...Remote job$230k
Nova Pneuma, Inc. in Fremont, CA seeks a Regulatory Manager to oversee regulatory strategies and submissions for product candidates. The ideal candidate will manage... ...requires 10-12 years of experience in regulatory affairs and a bachelor's degree in a scientific...$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience... ...with a strong focus on leading major submissions and ensuring regulatory compliance. This position...- 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
$186.23k - $279.35k
Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role Are you ready to steer global regulatory... ...interactions through major submissions and post‑approval maintenance—helping... ...submission activity. Experience with FDA advisory committee or EMA oral explanation...Hourly payTemporary workLocal areaFlexible hours$230k
Nova Pneuma in Colorado is seeking a Senior Regulatory Affairs Manager to oversee regulatory strategies and submissions for product candidates. The ideal candidate will have... ...regulatory authorities. A strong background in FDA regulations and drug safety is essential....$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...- ...Pharmaceuticals seeks a Director/Sr. Director for Regulatory Labeling Strategy to provide strategic regulatory... ...ensure compliance with FDA regulations. This role... ...in regulatory affairs and will contribute to innovative... .... Offers hybrid remote work options and a competitive...Remote work
- ...will be hybrid or remote and will require some... ...strategic regulatory advice and oversight... ...relevant US regulatory submissions, responses, and... ...liaison with the US FDA. This position... ...President, Regulatory Affairs. Essential... ...development of regulatory strategy and writing of...Remote workLocal area
$177k - $278.08k
...patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible... ...global regulatory strategies and providing strategic regulatory... ...Accountable for all US FDA submissions and approvals of project(... ...Takeda's Hybrid and Remote Work policy. Takeda Compensation...Remote workMinimum wageFull timeTemporary workLocal areaWorldwide- ...seeks a professional for regulatory oversight... ...including all US regulatory submissions and acting as the liaison with the FDA. A Bachelor's degree in... ...President of Regulatory Affairs. The ideal candidate should... ...role offers a hybrid or remote work environment with travel...Remote work
$124.4k - $207.4k
...LGBTQ+ business community. Please do not contact the recruiter directly. JOB SUMMARY The Senior Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology's regulatory...Full timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$168k - $252k
Job Summary The Regulatory Strategy Associate Director will oversee the development of regional... .... Oversee preparation, submission, and approval of... ...and regional regulatory affairs frameworks and guidelines... ...Hybrid‑eligible (up to two remote days per week) or on‑site...Remote work2 days per week$205k - $341.6k
...Director Regulatory Affairs – responsibility in global regulatory activities with a focus on Clinical... ...activities, and lead IND/CTA and BLA submissions. Typical day responsibilities Interpret... ...you if Strong understanding of US FDA and international guidance, regulations...Local areaRelocation package- ...is seeking an experienced Director of Regulatory Affairs to provide strategic and operational... ...in guiding regulatory strategy, ensuring compliance, and... ...clients in a fully remote, East Coast–based role. Key... ...for regulatory strategy, submissions, and compliance across U.S...Remote workFull time
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