Senior Regulatory Lead Remote (FDA/EU)
Evergen
Evergen, a global CDMO in regenerative medicine, seeks a Sr. Regulatory Specialist for remote US operations. You will support product development with regulatory submissions, labeling, and compliance across multiple facilities, including West Lafayette, IN, and global sites. This role requires 6+ years in regulatory affairs in medical devices or pharma and offers strong benefits and a competitive salary. The position emphasizes collaboration with cross-functional teams, coordination of #J-18808-Ljbffr
$110k - $135k
...Integrated DNA Technologies is seeking a Regulatory Affairs professional to lead the creation of regulatory documents and ensure compliance with FDA and EU regulations. Located in Boulder, CO, this fully remote role requires a Bachelor's degree in a technical field and...Remote workSeniorRegulatory- Job-ID32400670Reference26-00910Remote50% Remote Job Description Key Responsibilities · Lead FDA audit and inspection readiness activities across the business... ...the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions. · Review and...Remote workSeniorRegulatory
- ...Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing... ...strategies, prepare submissions to FDA/European authorities, and guide labeling and claims compliance. Remote options within the United States are considered...Remote workSeniorRegulatory
- ...global footprint, the full-time Senior Compliance Lead will perform sanctions... ...streamline processes in a fully remote environment. Key... ...circumvention risk and prepare regulatory reports as needed Coordinate... ...regimes, including US OFAC, EU, UK, and UN programmes Experience...Remote workSeniorRegulatoryFull time
- ...Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical... ...Solutions Regulatory affairs team. You will lead regulatory activities for new product... ...registrations, including 510(k) submissions, EU Technical Documents, and STEDs. The role...Remote workSeniorRegulatory
- ...OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices... .... The position offers flexible remote or hybrid on-site work in Madison, NJ with...Remote workSeniorRegulatoryFlexible hours
- ...Pharmaceuticals is seeking a Senior Manager of Epidemiology to lead non-interventional studies and support PMR/PMC regulatory commitments. You will identify... ..., and Regulatory. This remote-capable role offers collaboration across US/EU teams and opportunities to...Remote workSeniorRegulatory
- ...Experis Technology Group is seeking a Senior Regulatory Affairs Specialist in Santa Clara, CA, onsite. The role focuses on developing and improving... ...registrations, and ensuring compliance across US and EU markets. You will collaborate with cross-functional teams to...SeniorRegulatory
$212k - $333.19k
...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will... ...manner.Accountable for US FDA submissions and approvals of... ...requirements. Knowledge of FDA, EU, Canada, ROW and post-... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-...Remote workSeniorRegulatoryMinimum wageLocal areaWorldwide$109k - $174.8k
...Job Function: Regulatory Affairs Group Job Sub... ...States of America, Remote (US) Job Description... ...best talent for a Senior Regulatory Affairs Program Lead to support our Wound... ...obtain timely US and EU market access, including... ...and filing of FDA submissions (e.g., Q...Remote workSeniorRegulatoryLocal areaImmediate start- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global... ...role involves preparing submissions, leading communications with regulatory... ...regulatory affairs, particularly with FDA 510(k) and EU MDR submissions. Strong project management...SeniorRegulatory
$258.68k - $313.46k
...it.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...command of US experience and EU background desired.Thorough... ..., field-based and remote-by-design. The model assigned... ...Account.R1603594 : Senior Director, Global Regulatory...Remote workSeniorRegulatoryHourly payFull timeSummer workLive inLocal areaFlexible hours$72.6k - $145.2k
...function sits at the intersection of regulatory accountability and technology,... ...looking for a Sr. Compliance Associate Lead, Sanctions Operations to join us fully remote. This role reports directly to... ...major sanctions regimes: US OFAC, EU, UK and UN programmes. ~ Experience...Remote workSeniorRegulatoryFull timeLocal area- ...Publications - Sponsor Dedicated - Remote Based Syneos Health is a leading fully integrated... ...Adheres to established regulatory standards, including, but... ...worked with 94% of all Novel FDA Approved Drugs, 95% of EMA... ...the implementation of the EU Equality Directive, in relation...Remote workSeniorRegulatoryContract workFlexible hours
- ...headquartered in Dortmund, Germany. We are seeking a Senior Digital Ads Manager to own Meta and Google Ads across EU markets, from creative testing to bidding... ...like TikTok and Pinterest while enjoying a top-market salary and remote EU work. #J-18808-Ljbffr MuyRemotoRemote jobSenior
- ...Worldwide Clinical Trials is seeking a Senior Site Activation Manager to lead study start-up and site activation... .... The role emphasizes leadership, regulatory compliance with ICH GCP, and... ...process improvements. The position is remote with collaboration across time zones...Remote workSeniorRegulatoryWorldwide
$160.8k - $201k
...The Associate Director of Regulatory Labeling and Disclosures is a US remote based position. You will be responsible for leading global labeling activities... ...cross-functional study teams, senior management) and external... ...to clinicaltrials.gov, EU CTIS, and similar databases...Remote jobSeniorRegulatoryWork at officeLocal areaImmediate startWorldwide- RemoteFetch seeks a Senior Project Manager / Technical Product Manager to own wheel loader and skid steer product definition... ...teams from concept to mass production, ensuring regulatory compliance (EPA Tier 4 Final, EU Stage V) and field performance. You will translate...Remote jobSeniorRegulatory
- ...The Senior Facilities Program Specialist (FPS) Supervisor at General Dynamics Information... ...inspections and monitoring activities for regulatory compliance. This remote role requires travel up to 25% and offers the chance to lead complex assessments, coordinate...Remote workSeniorRegulatory
- ...ICF is seeking a Senior Archaeologist to join our West region with a focus on the Great... ...Basin. This role offers fully or partially remote work and welcomes candidates across... ...with interdisciplinary teams to deliver regulatory compliance solutions for clients. #J-1...Remote workSeniorRegulatory
- ...Scorpion Therapeutics seeks a Lead for CMC formulation and manufacturing development to... ...biopharma products toward rapid registration and regulatory submissions. You will provide strategic... ...-paced, data-driven environment. This senior role requires 7+ years in biopharma, a...Remote workSeniorRegulatory
- ...Block seeks a Senior Business Resilience Program Manager to lead and mature the company’s resilience program, spanning continuity, disaster recovery, crisis management, and regulatory compliance. You will translate resilience requirements into actionable steps, drive testing...Remote workSeniorRegulatory
- ...Keeper Security seeks a Senior Compliance Program Manager to drive regulatory compliance and security governance across enterprise and federal environments. This role is remote from select locations with possible hybrid schedules for Chicago or El Dorado Hills.) The...Remote workSeniorRegulatory
- ...Aldevron, a Danaher operating company, seeks a Senior Program Manager for plasmid DNA programs. This remote role leads complex, multi-program delivery from... ...will align scope, schedule, and cost, ensure regulatory readiness and supply continuity, and work across...Remote workSeniorRegulatory
- ...Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and drive timely product approvals across... ...medical device regulatory submissions (510(k), EU MDR) and audits (ISO 13485, MDSAP), with remote/work-from-home flexibility #J-18808-...Remote workSeniorRegulatoryWork from home
- ...Jobgether SRL is seeking a Senior Data Analyst to lead data analysis, validation, and regulatory reporting for Medicare Advantage supplemental benefits, ensuring data... ...forecasting, pricing, and performance management. This remote role requires strong analytical skills,...Remote workSeniorRegulatory
- ...NTT DATA sucht einen Lead/Managing Consultant im Bereich BFSI Regulatory & Compliance. Du leitest regulatorische Assessments, Roadmaps und Transformationsprojekte, arbeitest an Operating Models, Governance-Strukturen und Kontrollen und stehst im engen Austausch mit Stakeholdern...Remote workSeniorRegulatory
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workSeniorRegulatory$270k - $290k
...lifileucel) is the first FDA-approved, one-time... ...Iovance’s broad, industry-leading patent portfolio is available... ...Overview The Senior Director, Program Team... ...connects clinical, CMC, regulatory, and commercial... ...about within an office or remote workspace and exert up...Remote workSeniorRegulatoryFull timeWork at officeLocal areaWorldwideShift work- A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy... ...global regulations. The position offers a competitive salary and the flexibility of remote work. #J-18808-LjbffrRemote workSeniorRegulatory
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