Senior Regulatory Affairs Lead - Inhaled Therapies (Remote)
Avalyn Pharma
Avalyn Pharma is seeking a Senior Manager, Regulatory Affairs to shape global regulatory strategy for inhaled drug-device products. You will lead regulatory submissions, health authority interactions, and cross‑functional planning from early development through late-stage clinical programs. You will work with Clinical Development, CMC, and Quality teams to ensure compliant deliverables, maintain regulatory systems, and drive process improvements in a fast‑paced biotech environment. #J-18808-Ljbffr
$212k - $333.19k
...delivers transformative therapies to patients. By focusing... ...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will... ...within regulatory affairs and implications across the... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workSeniorMinimum wageLocal areaWorldwide- ...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 workSenior
$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 workSenior- 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 workSenior
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote workSenior
- ...Legend Biotech US seeks a Sr. Cell Therapy Clinical Educator for the New York area. The role focuses on providing education about Legend... ...responsibility for training within a defined region. It is a remote-based, field-facing position supported by the commercial team....Remote workSenior
- ...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 development and oversee global registrations, including 510(k) submissions, EU Technical Documents...Remote workSenior
$107k
...telehealth organization in California, seeks experienced BCBAs to lead clinical services and supervise teams. The role supports social... ...annual compensation, plus generous benefits and ongoing professional development in a remote California setting. #J-18808-LjbffrRemote workSenior$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 workSenior- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotics. You will collaborate with engineering and clinical teams to advance robotic instruments and accessories through global submissions and approvals. The...Remote jobSenior
- ...United States is seeking an Associate Director Oncology Treatment Site Lead (TSL) to support operational readiness and execution at treatment sites for an upcoming U.S. oncology mRNA neoantigen therapy for early-stage melanoma. The role will lead site onboarding, deliver...Remote jobSenior
- Fresenius Kabi USA in Lake Zurich, IL, seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making for complex products, guiding execution... ...-functional teams. Onsite 3 days per week with some remote work, the position collaborates with regulatory agencies...Remote workSenior3 days per week
- ...Syneos Health is seeking a Senior Medical Writer Publications - Sponsor Dedicated - Remote Based to lead and manage medical writing deliverables... ...ensure accuracy, maintain regulatory compliance, and mentor... ..., biostatistics, regulatory affairs, and medical affairs. The...Remote workSenior
$109k - $174.8k
...their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...Jersey, United States of America, Remote (US) Job Description: About... ...searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Wound Closure and...Remote workSeniorLocal areaImmediate start- AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead the development and implementation of US and Canada regulatory strategy for... ...environments, and a hybrid schedule (3 days in office, 2 remote) at #J-18808-Ljbffr BioSpaceRemote workSeniorWork at office
- Compass Pathways plc is seeking a Senior Manager to lead REMS and specialty pharmacy operations in the... .... Hybrid work from Jersey City HQ or remote on the East Coast, with cross-functional collaboration across Regulatory Affairs, Quality, and Commercial teams to translate...Remote workSenior
$110k - $135k
Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory... ...life sciences and diagnostics. You will lead the creation of regulatory documents and... ...vitro diagnostics. This position is fully remote, offers a salary range of $110,000 - $1...Remote jobSenior- ...creates treatment plans, and provides individual, group, and family therapies within a multidisciplinary setting supervised by a staff psychiatrist. The role is hybrid: in‑office on Mon, Tue and Fri; remote on Wed and Thu. You will manage a full caseload, document...Remote workSeniorWork at office
- ...pharmacy services across practices, ensuring high-quality, cost-effective care with regulatory compliance. You will collaborate with leadership and McKesson teams to drive optimized therapy, PET&P improvements, and risk mitigation. Oncology expertise and strong data...Remote jobSenior
$109k - $174.8k
...recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory... ...Jersey, United States of America, Remote (US), Santa Clara, California,... ...searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation & Accessories...Remote workSeniorLocal areaImmediate start$258.68k - $313.46k
...it.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...impact BMS, regulatory affairs or projects and provides... ...design, field-based and remote-by-design. The model assigned... ...Account.R1603594 : Senior Director, Global Regulatory...Remote workSeniorHourly payFull timeSummer workLive inLocal areaFlexible hours$165.49k - $227.55k
...currently looking for an ambitious Senior Research Lead to join our Endovascular... ...business within Advanced Therapies. We are a global technology... ...an autonomous and remote robotics system focused on... ...product-development objectives, regulatory considerations, and the commitments...Remote workSeniorTemporary workLocal area- ...Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead high‑quality submissions for cell therapy products. This role collaborates across technical and quality teams to support development through licensure...Senior
$259.08k - $396.2k
...class and best-in-class targeted cancer therapies. We are advancing an innovative... ...targets.Position OverviewAs the Global Regulatory Lead at Immunome, you will be the key decision... ...report to the Vice President, Regulatory Affairs.ResponsibilitiesRegulatory Strategy DevelopmentDefine...SeniorLocal areaFlexible hours$150k - $180k
Senior Manager, Regional Regulatory Lead - US HematologyCSL Research & DevelopmentLocation: King of Prussia, PA... ...committed to developing innovative therapies that make a meaningful difference for... ...(GRS) within Global Regulatory Affairs (GRA). This individual will contribute...SeniorFull timeWorldwide- ...Kite Pharma is seeking an experienced Regulatory Lead to drive strategy and submissions across US regulatory programs. The role requires... ...have extensive experience with FDA processes, global regulatory affairs, and a track record of successful submissions in oncology or...Remote work
- ...Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive... ...position promotes a collaborative work environment with flexible remote options. #J-18808-LjbffrRemote workFlexible hours
$160.8k - $201k
...launched our fourth therapy and the first ever... ...Director of Regulatory Labeling and Disclosures is a US remote based position. You... ...be responsible for leading global labeling activities... ...study teams, senior management) and... ...Global Regulatory Affairs team, cross functional...Remote jobSeniorWork at officeLocal areaImmediate startWorldwide- Immix Biopharma, Inc. in the United States is seeking an Associate Director of Regulatory Affairs for cell therapy. You will support regulatory strategy and execution for clinical trials under FDA/EMA/other regulations, preparing, submitting, and maintaining regulatory...Senior
- ...Jobgether is hiring a senior security governance professional to lead cross-functional risk, compliance, and AI governance initiatives. The role focuses on executing security programs, coordinating SOC 2 ISO 27001 and PCI-DSS audits, and driving remediation with accountable...Remote workSenior
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