Senior Regulatory CMC Lead, Oncology - US Remote
Sumitomo Pharma
Austin, TX
- Remote job
Sumitomo Pharma America (SMPA) seeks a Senior Manager, Regulatory Affairs CMC (Oncology) to join the Global Regulatory Affairs team in the US. The role focuses on regional CMC regulatory lead, coordinating submissions and responses to Health Authority requests, partnering with CMC, Quality, Manufacturing and cross-functional teams. Primarily remote with periodic on-site meetings, and travel as needed. Requires at least 6 years in regulatory affairs, with strong eCTD writing and NDA/BLA #J-18808-Ljbffr Sumitomo Pharma
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory CMC Lead, Oncology - US Remote in Austin, TX vacancy
$232k - $290k
...is a late-stage clinical oncology company developing novel... ...Reporting to the VP US Medical Affairs Strategy Lead, the Senior Director, US Medical Affairs... ..., Business Development, Regulatory, Safety, and Compliance... ...preferred. #LI-VN1 #LI-Remote The base pay salary...Remote workSeniorRegulatoryFull timeLocal areaRevolution Medicines
Remote1 day ago$144.06k - $205.8k
...areas that include oncology, ophthalmology,... ...role in the Regulatory Affairs department... ...Manufacturing and Controls (CMC) aspects of... ...CMC regulatory lead for highly... ...experience of EU, US and/or Japan... ...Westborough, MA. Remote work from anywhere... ...with senior leadership and governance...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- ...DirectorJob Description - CMC Team Leader, Sr.... ...diseases. The lead CARTA (Chimeric Antigen... ...and connect with us on LinkedIn.... ...OperationsLocation: [Remote]Department: Technical... ...Manufacturing, Quality, Regulatory Affairs, Supply... ...recommendations to senior leadership in a concise...Remote workSeniorRegulatory
$111k - $149k
Biogen in the United States is seeking a Senior Regulatory CMC Device and Combination Product Lead to provide regulatory expertise for global strategies, with focus on device and combination products. You will collaborate with cross-functional teams, lead regulatory submissions...Remote jobSeniorRegulatory- Orchard Therapeutics is seeking a US Regulatory Lead to drive regulatory strategy and execution for ex-vivo gene therapy programs. This role... ...PharmD/PhD, and a regulatory certification. This role offers remote work with a US market focus and comprehensive benefits. #J-1...Remote workSeniorRegulatory
$212k - $333.19k
...advancing a rapidly growing oncology portfolio with potentially... ....Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will... ...timely manner.Accountable for US FDA submissions and approvals... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-...Remote workSeniorRegulatoryMinimum wageTemporary workLocal areaWorldwide- ...mid-sized global CRO seeking a Senior CRA to lead independent oncology monitoring across diverse studies... ...site visits, data quality, and regulatory submissions while collaborating... ...ICH GCP guidelines. You will work remotely within the US, supported by a knowledgeable team...Remote jobSeniorRegulatory
$212k - $333.19k
...you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in... ...asset strategy and leads all development and... ...driving regulatory approval as well as... ...Pharmaceutical Sciences (CMC) Subteam, etc. to... ...Takeda’s Hybrid and Remote Work policy. #LI-JT...Remote workSeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaNight shift$140k - $210k
...medicines, including leading therapies for sleep... ...therapeutics in oncology and neuroscience. Jazz... ...: The Senior Manager, Regulatory Affairs Global CMC will be responsible... ...skills. #LI-SM1 #LI-remote Jazz Pharmaceuticals... ...protected by law. FOR US BASED CANDIDATES...Remote workSeniorRegulatoryFull timeWorldwideFlexible hoursJazz Pharmaceuticals
Remote1 day ago- ...including immunology, oncology and neuroscience - and... ...AbbVie, please visit us at Follow @abbvie on... ...Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing... ...and Controls (CMC) works with internal... ...days in office & 2 days remote) from the Waltham, MA...Remote workSeniorRegulatoryWork at officeLocal area
AbbVie
North Chicago, IL20 days ago $161.93k - $281k
Job DescriptionMedical Lead Oncology, MA-US (NSCLC)About Astellas Astellas is a global life sciences... ...and global strategy Collaborate with Regulatory Affairs and Pharmacovigilance in the... ...position is based in Northbrook, Illinois. Remote work from anywhere in the US is...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide$161.93k - $243.5k
...DescriptionSetidegrasib Launch Lead (NSCLC), US OncologyAbout... ...areas that include oncology, ophthalmology, urology... ...with medical, legal, regulatory, market access, sales... ...teams and influence senior stakeholders across... ...Northbrook, Illinois. Remote work from anywhere in...Remote workRegulatoryWork at officeWork from homeWorldwideFlexible hours$170.45k - $243.5k
...disease areas that include oncology, ophthalmology, urology... ....Purpose & Scope The Lead (Director), Medical Value Evidence (MVE), MA-US is accountable for... ...commercial functions and Regulatory Affairs to identify collaborative... ...Northbrook, Illinois. Remote work from anywhere in...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide$154.4k - $242.55k
...Brand Insights and Analytics Lead, US Oncology is an Associate Director-... ...collaborate effectively with senior management.Thorough knowledge... ...simultaneouslyKnowledge of regulatory requirements and compliance... ...accordance with Takeda's Hybrid and Remote Work policy. #LI-...Remote workRegulatoryMinimum wageTemporary workLocal area$199.22k - $284.6k
...areas that include oncology, ophthalmology, urology... ...is accountable for CMC activities... ...transition. The CMC Lead serves as the single... ...development, manufacturing, regulatory, quality, supply... ...governance bodies, senior leaders, and... ...Collaboration across EU, US, and Japan time...SeniorRegulatoryWork at officeWork from homeWorldwide$202.13k - $336.88k
...DPosition Summary:As the Senior Director, Early Phase CMC Medicine Research... ...matrix leaders who lead programs in support... ...chain, quality and CMC regulatory strategy through... ...qualifications to help us achieve our goals... ...immunology and inflammation; oncology; HIV; and infectious...SeniorRegulatoryFull timeLocal area- ...experience managing global Oncology/Hematology trials. The Senior Project Manager serves as the Project Lead and primary sponsor contact... ...organization policies, SOPs, ICH- GCP, regulatory and project specific... ...and gloves. Why Join Us? When you join Thermo Fisher...Remote workSeniorRegulatoryFull timeContract workWork at officeRemote3 days ago
- ...clinical trials to regulatory, consulting, and market... ...what we do.Each of us, no matter what we... ...is seeking a Senior Clinical Research Associate... ...is experienced in Oncology On-Site Monitoring... ...onsite, remote/electronic monitoring... ...influence, drive / lead and work through others...Remote workSeniorRegulatoryFull timeLocal area
- ...therapeutic areas including immunology, oncology and neuroscience - and products... ...about AbbVie, please visit us at . Follow @abbvie on... ...Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is responsible for the development...SeniorRegulatoryFull timeLocal area
AbbVie
Cambridge, MA19 days ago $234.1k - $283.67k
...com/working-with-us .At Bristol... ...through science. In oncology, hematology,... ...Scientific Director, CMC Team Leader is... ...developing and leading the execution... ..., quality, regulatory, and clinical supplies... ...Required - Senior Director:... .... Employees in remote-by-design or lab...Remote workSeniorRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...therapeutic areas including immunology, oncology and neuroscience - and products... ...about AbbVie, please visit us at Follow @abbvie onLinkedIn,... ...XandYouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is responsible...SeniorRegulatory
- ## Senior Lead Insider Threat Investigator (US)Postulerremote type: À distancelocations: Mount Laurel, New Jersey: Remote Charlotte (NC): Remote Port Charlotte (FL)time type: Temps pleinposted... ...leads thematic, complex (i.e., regulatory/ public private partnerships) investigative...Remote workSeniorRegulatoryTemporary workWork at officeLocal areaWork from homeFlexible hours
- ...Location: Remote Who we are? Optimapharm is a... ...we enable accelerated regulatory pathways, faster study... ...environment. As our US Clinical Operations team... ..., we're looking for a Senior CRA who is committed to... ...monitoring experience in oncology High level of...Remote workSeniorRegulatoryContract workInterim roleWorldwide
Optimapharm d.o.o.
United States3 days ago $169.5k - $248.6k
...for patients, we invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global... ..., IN and relocation is provided, remote is not available for this role.Additional...Remote workSeniorRegulatoryLocal areaRelocationFlexible hours$244k - $305k
...late-stage clinical oncology company developing... ...continue to grow our US Medical Affairs... ..., we are seeking a Senior Director of Medical... ...Content & Training to lead the development,... ...Clinical Development, Regulatory, Commercial, Legal,... ...-office based or remote with ability to travel...Remote workSeniorRegulatoryFull timeLocal areaHome office- ...including immunology, oncology and neuroscience... ..., please visit us at . Follow @... ...Description The Senior Associate, RA CMC is responsible... ...departments in support of regulatory filings.... ...with RA CMC Project Leads to create and... ...office & 2 days remotely) from the Lake County...Remote workSeniorRegulatoryTemporary workWork at officeLocal area
AbbVie Inc.
North Chicago, IL11 days ago - ...based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative... ...of successful submissions. This position promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workRegulatoryFlexible hours
$258.68k - $313.46k
...bms.com/working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...areas – Drug Development/CMC/Pharmtox/... ...centers. Employees in remote-by-design or lab-based... ...with Ripley.R1603594 : Senior Director, Global Regulatory...Remote workSeniorRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$244k - $305k
...is a late-stage clinical oncology company developing novel... ...pathway.The Opportunity:The Senior Director, Molecule Global Regulatory Lead will develop and execute... ..., Biometrics, and CMC to deliver high-quality global... ...website and when contacting us by email or phone. We...SeniorRegulatoryFull timeLocal area- ...Director, Global Regulatory Strategy- Oncology is responsible for... ...Regulatory Lead responsibilities... ...teams.Partner with senior stakeholders to support... ...presence at a US site for leadership... ...key meetings. Remote-first candidates... ...Commercial, Statistics, CMC, and other R&D...Remote workRegulatoryFull timeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory CMC Lead, Oncology - US Remote. Be the first to apply!
Related searches
- senior maintenance supervisor Austin, TX
- senior lead project manager Austin, TX
- senior robotics software engineer Austin, TX
- senior firewall engineer Austin, TX
- senior devops engineer remote Austin, TX
- senior sas administrator Austin, TX
- senior IT manager Austin, TX
- senior director of client services Austin, TX
- senior contracts analyst Austin, TX
- senior implementation consultant Austin, TX