Senior Regulatory CMC Lead - Device & Combo Products (Remote)
$111k - $149kUnited States Digital Space LLC
- Remote job
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, and help advance processes aligned with business objectives. This role offers visibility across the organization, a base compensation range of $111,000 to $149,000, and a comprehensive benefits package including health, #J-18808-Ljbffr United States Digital Space LLC
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...life‑changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...implementation of innovative pure device and combination product regulatory strategies particularly pertaining to...SeniorRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- .... in the United States is seeking a Senior Regulatory Affairs Product Associate for the Peripheral Business... ...strategies for implantable medical devices, manage global submissions, and partner... ...the product lifecycle. This remote role requires at least Bachelor's degree...Remote jobSeniorRegulatory
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...Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide... ...How you will contribute:Leads and develops a team of... ...Regulatory Affairs in senior-level governance and... ...following Takeda's Hybrid and Remote Work policy.#LI-...Remote workRegulatoryMinimum wageTemporary workWork at officeLocal areaWorldwide$190.8k - $300.3k
...DescriptionDirector/Principal Scientist, Devices and Drug-Device Combinations Regulatory CMCReporting to the... ...Drug-Device Combinations CMC is responsible to support... ...other delivery system products in accordance with global... ...to:Responsibilities:Lead Device Regulatory Affairs...Remote workRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours- ...pharmaceutical products that significantly... ...is a fully remote‑based company with... ...Title: Senior Manager, Quality... ...Control - Drug‑Device Combination ProductsQuality... ...Assurance, Regulatory Affairs,... ...and act as a QC lead during FDA, EU,... ...contributing to CMC sections of U.S...Remote workSeniorRegulatoryContract work
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$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime type: Full timeposted on: Posted 2 Days Agojob... ...clinical research, clinical supply chain, CMC, quality, regulatory, program & portfolio management.This role will include direct...SeniorRegulatory$157.59k - $203.94k
...possible, together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible for supporting CMC regulatory... ...Affairs Combination Product and Device Lead for assigned device and combination product programs...SeniorRegulatoryFull timeFor contractorsLocal area$80 - $95.76 per hour
...Manager III (non-IT) to lead cross-functional program management for New Product Introductions (NPI) and... ...-Thu onsite; Mon/Fri remote). If you bring deep expertise... ...launches for medical devices and combination... ...Manufacturing, Quality, and Regulatory. Utilize Microsoft Project...Remote workSeniorRegulatoryHourly payContract workTemporary workWork experience placement- ...healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville,... ...support the commercialization of its digital products and AI technologies. The role involves... ...communication skills. This position is remote and requires some travel. Competitive...Remote jobSeniorRegulatory
$169.5k - $248.6k
...About the RoleAs the Global Regulatory Lead (GRL), you will be the... ...health authority guidance, and product-specific regulatory advice... ...of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global LabelingFoster... ...relocation is provided, remote is not available for this...Remote workSeniorRegulatoryLocal areaRelocationFlexible hours$139k - $239k
...of the United States' leading providers of financial... ...planning, and retirement products and services to help... ...Fargo is seeking a Senior Lead Product Manager... ...functional teams to ensure regulatory compliance and... ...the office and 2 days remote Ability to travel up...Remote workSeniorRegulatoryFull timeWork experience placementWork at office$137k - $215.27k
...is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices organization, and will... ...some supervision, leads the execution of regulatory... ...for assigned products.RA CMC member on the Global... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workSeniorRegulatoryMinimum wageTemporary workLocal areaWorldwide$235k - $265k
...business unit, established to lead commercialization in the... ...About This Role The Senior Director, Global Regulatory Lead (GRL) — Devices & Regenerative... ...other innovative aesthetic products. You will develop, maintain... .../clinical strategy, CMC, design controls, and global...SeniorRegulatory- ...connected care. As Group Product Manager, Device Cloud Platform (IoT),... ...role in defining and leading the evolution of... ...air software delivery, remote configuration, cloud-... ..., data, clinical, regulatory, quality, operations,... ...skills, especially with senior stakeholders. What...Remote workRegulatoryFull timeTemporary workShift work
$122.25k - $176.58k
Job title: GRA Device Associate - Medical Devices and Combination Products (Senior Manager)Location: Morristown,... ...About the JobThe Global Regulatory Affairs (GRA) Device... ...team is part of the GRA CMC & GRA Device... ...with a drug product, leading regulatory efforts in...SeniorRegulatoryFull timeLocal areaWorldwide- Zendesk seeks a Senior Counsel, Product (AI) to provide strategic legal guidance for AI products and... ...candidates may be considered for a fully remote role outside of office locations. The role focuses on shaping AI strategy, regulatory compliance, and privacy considerations...Remote jobSeniorRegulatoryWork at office
$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...simultaneously driving regulatory approval as well as... ...to bring the product to market and to ensure... ...Pharmaceutical Sciences (CMC) Subteam, etc. to... ...Takeda’s Hybrid and Remote Work policy.Empowering...Remote workSeniorRegulatoryMinimum wageTemporary workWork at officeLocal area- BioRobotics is looking for a Principal Regulatory Affairs Specialist to provide regulatory leadership from product development through marketing approval in California.... ...requires a minimum of 12 years in the medical device industry, with strong knowledge of regulatory...SeniorRegulatory
- Viltis is seeking a Senior Regulatory Affairs Specialist to support a leading medical device organization in San Diego, CA. The ideal candidate brings 7+ years of Medical... ..., maintain regulatory compliance for marketed products, and assess impact of changes across the...SeniorRegulatory
$155k
...Mission-Driven: Work on a product that tangibly extends... ...The Role ~ Senior Product Manager who defines... ...how we execute delivery. Lead with a dual focus on vision... ...US clinical payment, regulatory, and operational environments... ...Others Location: Remote – must have significant...Remote workSeniorRegulatory- Abbott in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to support worldwide submissions and regulatory strategies for medical devices. The role collaborates with product teams and manufacturing to prepare filings and maintain licenses, registrations,...SeniorRegulatoryWorldwide
- Senior/Executive Director, Drug Product MS&T The Senior/Executive Director... .../autoinjector devices, with biologics.... ...validation, and regulatory filing activities... ...position is remote and will require... ...Experienced in authoring CMC sections for... ...experience leading a technical team...Remote workSeniorRegulatoryContract workFor contractors
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...ABOUT US: As a world leading provider of integrated... ....com The Product Leader - Loan Administration... ...controls, audit trails, and regulatory oversight. The ideal... ...and Engagement: As a senior leader, you will be... ...via Alter Domus webpage: ) #LI-REMOTE #LI-SM1...Remote workSeniorRegulatoryContract workLocal areaFlexible hours- PDDN INC. is seeking a Principal Regulatory Affairs Specialist to lead post-market regulatory activities in a... ...Engineering, and Commercial teams across the product lifecycle. Ideal candidates have 12+... ...regulatory affairs within medical devices, strong communication skills, and...SeniorRegulatory
$210.38k - $272.25k
...possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for... ...influencing strategy and decision-making across senior cross-functional stakeholders in complex,...RegulatoryFull timeFor contractorsLocal area
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