Remote Director, Regulatory Affairs — FDA Strategy & Submissions
Stryker Corporation
- 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
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney... ...leadership responsibilities in guiding key FDA interactions and overseeing submissions. The...SuggestedFlexible 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
$110k - $150k
...insights, is building a regulatory team to develop... ...medical devices and seek FDA marketing authorization... ...Manager of Regulatory Affairs will work closely with... ...lead global regulatory strategies to support business objectives... ...Lead and assist with submissions and correspondence...Remote job$270k - $300k
Description The Senior Director, Regulatory Affairs will report to the... ...global regulatory strategy for Pliant’s oncology... ...interactions with the FDA and other regulatory... ...long-term success. (Remote* = Must be in our S.... ...all interactions/submissions to global Health Authorities...Remote jobFull timeTemporary workWork at office- ...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
Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team... ...Summary: The Director, Regulatory Affairs Strategy is responsible for developing... ..., including the FDA, EMA, and other regulatory... .... Regulatory Submissions Oversee the preparation...Remote workFull timeTemporary workLocal areaWeekend work$200k - $235k
...journey of growth! Remote/Commuter... ...packages for the US FDA. Liaise with FDA for... ...Provide high‑level regulatory advice and identify... ...effective regulatory affairs cross‑functional team... ...regulatory strategies. Demonstrated record... ...participation in submissions to ex‑US authorities...Remote workWork at officeFlexible hours- ...Title: Regulatory Strategy Director Location: Boston, MA (Hybrid) Employment... ...regulatory submissions and Health Authority... ...in global regulatory affairs strategy within the pharmaceutical... ...experience FDA, EMA, MHRA, PMDA, or... ...extension ~ Remote considered for exceptional...Remote workContract work
$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....
$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....- 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
$248k - $280k
...Therapeutics is looking for a Director of Global Regulatory Strategy, responsible for developing and... ...interaction with the FDA and leading regulatory submissions. The ideal candidate will have... ...years of experience in Regulatory Affairs, preferable in the pharmaceutical...$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
$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- ...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
$144.38k - $240.63k
...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... ...of in‑office days and remote days. Competitive...Remote workWork at officeWorldwide- ...Description Job Description The Director, Regulatory Strategy is a key leadership role responsible... ...planning and decision-making. Regulatory Submissions: Oversee the preparation, review, and... ...to relevant authorities, including FDA, EMA, and other global agencies....Remote jobFull timeLocal area
$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... ...bring a strong understanding of US FDA and international pharmaceutical guidance...Full timeWorldwideRelocation package- ...next steps. Our partner is looking for a Director, Regulatory Affairs Strategy based in the United States. This is a... ...health authorities, including the FDA and EMA, to support critical milestones and regulatory submissions. You will guide teams through complex development...Remote jobFull time
$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- ...pharmaceutical company is seeking a Director or Associate Director of Regulatory Affairs in Round Lake, Illinois... ...developing regulatory strategies, overseeing submissions, and ensuring compliance with FDA guidelines. Candidates... ...pharmaceuticals. This remote workplace eligible...Remote work
$228k - $245k
...Overview The Director, Global Regulatory Affairs will play a critical role... ...implementing regulatory strategies to support the... ...Lead the preparation, submission, and maintenance of... ...authorities, including the FDA, EMA, MHRA and other... ...San Diego office. Remote permitted upon...Remote workFull timeSummer workWork at officeRelocation packageMonday to Friday- ...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
- ...hospitals, data centers, remote sites, and military bases.... ...deliveries beginning in 2028. Director of Regulatory Affairs Radiant is seeking a... ...oversee licensing engagement, strategy, process, and execution... ...licensing and regulatory submissions. Integrate our regulatory...Remote workFull timeSummer workImmediate startFlexible hoursWeekend work
$228k - $245k
...Overview The Director, Global Regulatory Affairs will play a critical role... ...implementing regulatory strategies to support the... ...Lead the preparation, submission, and maintenance of... ...authorities, including the FDA, EMA, MHRA and other... ...San Diego office. Remote permitted upon...Remote workFull timeSummer workWork at officeRelocation packageMonday to Friday$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 workFull timeWork at officeFlexible hours
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