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
$130k - $250k
...Diego is looking for a fully remote Director of Regulatory Affairs. This key role includes... ...regulations, developing strategies for product development... ...coordinating regulatory submissions. The ideal candidate will... ...extensive experience with FDA interactions and a strong...Remote job$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$135k - $150k
Jade Biosciences is hiring a Regulatory Affairs Manager to support regulatory strategies for their clinical-stage therapies. This remote position requires timely submissions and compliance with FDA regulations. Candidates should have extensive experience in regulatory...Remote job- ...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
$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- ...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...
- ...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- ...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
...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$135k - $150k
Jade Biosciences is looking for a Regulatory Affairs Manager to support the execution of regulatory strategies in a remote position. Responsibilities include managing submissions and ensuring compliance with global regulations. The ideal candidate will have 5-8+ years...Remote job$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- ...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....
- ...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...
- Discover International is seeking a Director of Regulatory Affairs CMC to oversee CMC regulatory strategies across development and commercial programs in the Boston... ...Regulatory CMC, with responsibilities including major submissions and Health Authority interactions. The ideal...
- Women Veterans Interactive is seeking a seasoned regulatory affairs professional in Chicago, Illinois, to oversee CMC regulatory product strategies and manage regulatory submissions. The candidate should have at least 10 years of experience in the biopharmaceutical sector...
- ALKU is seeking a senior Regulatory Affairs leader to oversee regulatory activities across the organization... ...this onsite role in California, you will shape strategies, oversee IND/CTA and NDA/BLA submissions, interact with the FDA and international authorities, and lead...
- ...Pharma USA Inc. is seeking a Regulatory Affairs CMC leader to steer global CMC regulatory strategies for development and commercial... ...preparation, review, and submission of high-quality CMC dossiers... ...regulatory requirements. The Director will lead cross-functional teams...
$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...- ...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...
$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...- ...Scientific is seeking a Senior Regulatory professional in the... ...the global regulatory strategy for a company... ...authorities like the FDA and EMA. Ideal candidates... ...experience in regulatory affairs, advanced degrees, and... ...record of NDA and BLA submissions. A competitive...
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy based in Washington, DC, to develop and execute global... .... This role involves leading regulatory submissions and engaging with health authorities like the FDA. The ideal candidate will have 10+ years...Remote job
$189k - $246k
Travere Therapeutics is looking for a Director of Regulatory Affairs Strategy to develop and execute regulatory... ...health authorities including the FDA and EMA. The ideal candidate will have... ...in managing major regulatory submissions. Competitive compensation includes...Remote job- ...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
- 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...
$235k - $285k
Septerna is seeking a Director/Senior Director of Regulatory Affairs in South San Francisco. This role involves leading regulatory strategy for clinical programs and managing submissions to health authorities. The ideal candidate will have over 10 years of experience in...- 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
$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....
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