US Regulatory Strategy Lead, Gene Therapy
Orchard Therapeutics plc
Orchard Therapeutics, a Kyowa Kirin company, is seeking a US regulatory expert to lead regulatory strategy and submissions for ex-vivo gene therapy programs. The role reports to the Executive Director, Regulatory Science and is based in Boston with a hybrid work model. The successful candidate will oversee US regulatory activities, engage with FDA, and drive lifecycle regulatory planning across clinical and manufacturing teams.
#J-18808-Ljbffr$94.4k - $266.3k
...taking notice of our work, too. Visit us here to find out more about Accenture's... ...understand how operational, financial, and regulatory reporting requirements translate into... ...and reporting architectures. You lead with strategy — designing frameworks that are sustainable...RegulatoryWork experience placementLive inWork at officeLocal area- ...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...RegulatoryRemote work
$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&... .... Director, Global Regulatory Labeling Strategy Join Takeda as Director, Global... ...alignment with TAU/MPD Labeling Lead, coordinates the process to... ...Team (GRT) Liaises with US Labeling Operations, EU Labeling...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwide- ...Regionally Aligned Across US Syneos Health® is a leading fully integrated... ...accelerate the delivery of therapies, because we are passionate... ...site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology... ...retention and awareness strategies. Enters data into...RegulatoryContract workInterim roleLocal areaImmediate startRemote workFlexible hours
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- ...three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our... ...diagnosis, management, and treatment of DEB Execute territory strategies focused on market development, brand awareness, and patient identification...Full timeFixed term contractWork at officeLocal areaNight shift
$107.5k - $188.4k
...Lead Technical Product Manager – UpToDate Growth Locations: Hybrid from on of our US based offices At Wolters Kluwer, we combine deep clinical... ...Responsibilities Growth Strategy & Expansion Define and drive... ...for clinical, privacy, and regulatory environments. User Insight...RegulatoryWork at office$205k - $265k
...delivering on the promise of gene therapy and delivering hope... ...of patients. Join us in making the impossible... ...setting multi‑year strategy and rolling up their sleeves... ...Operations, Quality, Regulatory, Commercial, Finance,... ...Build and lead the commercial supply...RegulatoryMinimum wageLocal areaWorldwide$150k - $195k
...deliver life-changing therapies to people living with... ...vision of becoming a leading biopharmaceutical company... ...closely with Quality, Regulatory Affairs, Clinical, and... ...-to-date knowledge of US and EU GMP... ...development of risk mitigation strategies. Ability to adapt to modification...RegulatoryContract workTemporary workRemote work- ...Medtronic is recruiting an IT Program Director to lead the transaction-level business process and systems strategy across the full lifecycle of acquisitions and... ...drive platform decisions that meet enterprise standards while ensuring regulatory compliance #J-18808-Ljbffr...Regulatory
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$164k - $282.9k
...healthcare innovation empowers us to build aworld where complex... ...Director, Health Systems Value Strategy to join our Orthopaedics team.... ...of the portfolio. Build and lead a Hospital Administrator Advisory... ...bodies, as may be required, regulatory approvals and other customary...RegulatoryContract workLocal areaImmediate startRemote workShift work$22 - $27 per hour
...contract assignment. (W-2) Key Responsibilities Lead end-to-end development of communication... ..., corporate messaging guidelines, and regulatory requirements. Oversee project timelines... ..., then this is the position for you! For us, our guiding principle has always been and...RegulatoryContract workWork experience placement- ...calling at Mercy! The position serves as a lead role within the departments working in... ...or nurse practitioner licensed by a State regulatory board to refill medication and assist with... ..., technology, and compassion. As we grow, you'll grow with us. #J-18808-Ljbffr...RegulatoryFull timeShift work
$200k
...Blue Owl (NYSE: OWL) is a leading asset manager that is redefining alternatives... ...2026, we invest across three multi-strategy platforms: Credit, Real Assets and... ...private market strategies. Knowledge of regulatory environments across the US. Ability to navigate these...RegulatoryPermanent employmentTemporary workFlexible hours- ...future brand and disease‑state strategies in three core areas: Market... ...commercial compliance, legal and regulatory guidelines. Join the team... ...innovative pipeline – enables us to invent medicines and vaccines... ...priorities Assemble and lead cross-functional teams toward...RegulatoryWork experience placementWork at officeLocal areaWeekend work
- ...Successful completion of an accredited (PT, OT) therapy assistant program. Licensure: Current... ..., educational methodologies, and regulatory standards, along with knowledge of planning... ...through innovation, technology, and compassion. As we grow, you'll grow with us....RegulatoryFull time
- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...to take on a pivotal role as the regulatory face of its lead program, which is in the registration stage and operates in a...Regulatory
- ...Head of Regulatory Affairs About the Company Clinical-stage biotech developing novel therapies for areas of significant unmet medical need Industry Biotechnology... ...Regulatory Affairs to establish and lead regulatory strategy for early-stage programs, from...Regulatory
$170k - $230k
...treatment and has Breakthrough Therapy designation from the U.... ...UK for TRD. We are leading the world's largest... ...to shape medical strategy, and supporting the continued... ...Uphold all ethical, regulatory, and compliance requirements... ..., please visit "Joins us - Our Benefits"....RegulatoryPermanent employmentWork at officeVisa sponsorshipWork visaNight shift- ...biotech focused on developing targeted therapies and next-generation immuno-... ...company is seeking a Senior Manager, Regulatory Affairs to support regulatory strategy and execution across key... ...activities through clinical development Lead preparation and coordination of regulatory...Regulatory
$171k - $273k
...Operations, Image Guided Therapy Devices The Director of Clinical... ...against goals while leading complex negotiations with regulatory bodies, sites, and... ...shape large-scale research strategy, analyze industry trends,... .... Additional Information US work authorization is a precondition...RegulatoryFull timeContract workWork at officeLocal areaWork visaRelocation package3 days per week- ...Therapist, provides occupational therapy services to individuals or... ..., local, state, and federal regulatory requirements by applying relevant... ..., treatment plan, and strategies for home management. Collaborates... ...of contact" serviceIndustry?leading pay rates, loyalty rewards &...RegulatoryTemporary workLocumLocal area
- ...Highmark Health is seeking a Quality Lead with data-testing leadership and healthcare domain expertise. The role focuses on strategy, oversight of quality activities, and communicating business impacts. Day-to-day hands-on testing is not required. The ideal candidate...Remote work
- ...Pantheon Health System, LLC seeks a Molecular Laboratory Supervisor to lead specialized molecular diagnostic testing, ensuring regulatory compliance and high-quality patient results. The role emphasizes instrument maintenance, data integrity, and staff oversight in a...Regulatory
$160k - $275k
...building an industry-leading pipeline of oral small... ...convenient, highly effective therapies for patients with... ...visit or follow us onX (formerly Twitter)... ...integrity and alignment with regulatory standards. Collaborate... ...implement mitigation strategies. Support IRB and...Regulatory- ...Research is looking for a Vice President, Regulatory Strategy to join our Regulatory Affairs team.... ...an essential part of our team, you help us deliver the medical innovation that... ...responsible for developing, implementing, and leading global strategy for assigned projects,...Regulatory
$112.9k - $338.3k
...management consultants helping leading organizations reinvent... ...future-ready customer service strategies, operating models, transformation... ...expectations, affordability pressures, regulatory requirements, outage and... ...creating 360° value, enable us to help our clients reinvent...RegulatoryFull timeWork experience placementLive inWork at officeLocal area
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