Senior CMC Regulatory Affairs Lead - Global Submissions
AbbVie
AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs (CMC) to lead regulatory initiatives for chemistry, manufacturing and controls, including biologics programs. You will coordinate with global teams and external partners to craft submissions and support first-pass approvals. The role supports INDs/CTAs, variations and annual reports with a hybrid schedule (3 days in office, 2 days remote) from the Waltham, MA and Lake County, IL headquarters, offering a comprehensive #J-18808-Ljbffr AbbVie
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior CMC Regulatory Affairs Lead - Global Submissions in North Chicago, IL vacancy
- ICU Medical is seeking a Regulatory Affairs professional to support global and US registrations for device electro-mechanical products. You will analyze requirements... ...dossiers while ensuring full compliance of submissions and change management. You will coordinate with...Senior
- ...Inc. in the United States seeks a Program Manager, CMC Dossier Management to oversee regulatory submission content plans, source document mapping, and timelines... ...You will coordinate with CMC RA and functional area leads to monitor milestones and manage risks. The role requires...Senior
- ...Inc. in North Chicago is seeking a Program Manager, CMC Dossier Management to lead and oversee CMC regulatory deliverables, including INDs/IMPDs and marketing... ...drive process improvements while ensuring on-time submissions and accurate content plans. #J-18808-Ljbffr AbbVie...Senior
$124.5k - $236.5k
Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) Full-time Salary Min: 124500 Salary Max: 236500 Workday Global Grade: 19 Compensation: USD 124,500 - USD 236,500 - yearly... ...content strategy for regulatory submissions, including INDs/CTAs and...SeniorFull timeWork at officeRemote work- ...X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director... ...and review of regulatory submissions consistent within US and Canada regulatory...SeniorWork at officeRemote work
$124.5k - $236.5k
Senior Manager, Clinical Quality Assurance Full-time... ...Max: 236500 Workday Global Grade: 19 Travel: Yes... ...responsible for leading the management of GCP... ...program with the goal of submission-ready quality data,... ...inGCPquality assurance or regulatory affairs or clinical...Full timeLocal area- AbbVie seeks a Senior Associate, Regulatory Affairs Submission Management to drive medium-to-high impact submissions. You will coordinate cross-functional teams, establish content planners, and partner with publishing vendors to deliver high-quality dossiers on time. The...
- AbbVie's Senior Manager, Regulatory Strategic Planning role focuses on delivering project management... ...teams within Regulatory Affairs. You will manage schedules, deliverables... ...AbbVie’s regulatory strategies globally. The role requires leading GRPT-related activities,...Work at office
- ICU Medical seeks a seasoned Regulatory Affairs professional to provide global and US registration expertise for electro-mechanical device products. You will analyze requirements, prepare registration dossiers, ensure documentation compliance, and support regulatory strategy...Senior
- ...duration ; May extend Job Title Regulatory Affairs Manager Responsible for... ...product information across global markets. 3 days onsite... ...PRAC recommendations • Lead continuous improvement and... ...for improved safety variation submission process and related system...SeniorFull timeRemote work
Cube Hub Inc.
Deerfield, IL11 hours ago - AbbVie is seeking a Senior Manager, RDQA AREA, to lead quality assurance across US Affiliates. The role focuses on proactive quality management, collaboration... ...systems, audits, and inspections readiness in a complex regulatory landscape, with travel up to 35% and leadership of...Senior
- A global biopharmaceutical leader is seeking an Associate Director for Global Quality and Compliance Excellence. This role involves leading regulatory inspections, ensuring compliance across facilities, and advancing a strong quality culture. Candidates should have a strong...
- ...quality project outcomes while ensuring compliance and maintaining strong external partnerships. The role emphasizes cross-disciplinary leadership, innovative thinking, and proactive problem-solving within a global pharmaceutical environment. #J-18808-Ljbffr AbbVie Inc.Senior
- ...information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube. The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-...SeniorWork at officeRemote work
- AbbVie Inc. is seeking a Senior Manager Regulatory Affairs to lead the development and execution of regulatory... ...meetings, and ensures timely regulatory submissions across therapies. The position... ...Lake County, IL area and AbbVie global sites. Strong collaboration with cross...SeniorWork at officeRemote work
- ...(Biologics ARD) is a global analytical sciences organization... ...responsible for CMC analytical activities... ...of industry-leading analytical capabilities... ...process understanding, and regulatory submission content. Major Responsibilities... ...with peers and senior management. Mentor peers...Work experience placement
- ...Borrowers, title companies, attorneys and contractors to ensure proper draws. The role emphasizes documentation, funding coordination and regulatory compliance, with an in-office Midwest-based posture and a comprehensive benefits package. #J-18808-Ljbffr Old National BankSeniorFor contractorsWork at office
- AbbVie is seeking a Quality Assurance Auditor to plan and conduct audits across clinical, pre-clinical, and CMC documentation within the Quality Dossier Program. You will review responses, maintain schedules, and represent RD QA in cross-functional meetings to drive compliance...Senior
$124.5k - $236.5k
...Description The Program Manager, CMC Dossier Management assists... ...project plans to support CMC regulatory deliverables such as INDs/... ...monitoring the progress of regulatory submissions deliverable against timelines... ...CMC RA and functional area leads; assists with the...Senior$97.5k - $139.75k
Position Summary Provides regulatory support and expertise associated with global and US registration of... ...of alldocumentationfor submissions and change management.... ...Global Regulatory Affairs at research and development... ...positions. May serve as a lead regulatory...SeniorWork at officeLocal area$117.3k - $195.5k
...Support KPI definition and lead dashboard design... ...stakeholders of different seniority levels, including... ...Impact team and Medical Affairs executive-level stakeholders... ..., patient/consumer, regulatory, and media. In depth... ...in Pfizer’s Global Performance Plan with...SeniorRemote workRelocation packageFlexible hours- ...supporting the Product Safety Leads (PST) and potentially support... ...Area (TA) Lead and Global TA. Head in ensuring safety in... ...medical safety assessments, regulatory responses and risk management... ...safety strategy for regulatory submissions, including INDs, NDAs, and MAAs...SeniorLocal area
- Position Summary Provides regulatory support and expertise associated with global and US registration of... ...all documentation for submissions and change management.... ...Represents Global Regulatory Affairs at research and... ...positions. May serve as a lead regulatory...SeniorWork at officeLocal area
- ...and YouTube. Program Manager, CMC Dossier Management The... ...project plans to support CMC regulatory deliverables such as INDs/IMPDs... ...Marketing Applications. Regulatory submission content plans, source... ...with CMC RA and functional area leads; assists with the identification...SeniorLocal area
- AbbVie in North Chicago seeks a Senior Clinical Site Management Leader to direct global/area CSM strategy and execution across assigned studies. You will lead site monitors, guide study timelines, and coordinate with the Clinical Study Team to ensure quality, risk management...
- AbbVie seeks a senior EHS leader to drive global regulatory compliance, monitor impacts, and oversee risk management across sites worldwide. You will guide regulatory updates, KPIs, and training, while reducing liability and supporting a safe, sustainable business. Role...Worldwide
- ...Instagram, X and YouTube. Purpose Job Description The Global Connected Logistics and Internet of Things (IoT) Strategy Lead shapes and advances enterprise capabilities that... ..., Regional Transportation Management teams and senior cross‑functional leaders to address partner...Local area
- AbbVie is seeking a senior strategy lead for Global Connected Logistics and IoT to shape enterprise capabilities across the distribution network. The role connects business strategy with practical implementation, coordinating requirements regionally and with external providers...
- AbbVie Inc. is seeking a Risk Management Lead to advance risk-based quality management across global clinical trials. You will partner with study teams to embed... ...to ensure high-quality study execution and regulatory compliance. The ideal candidate has a Bachelor’s...
- ...YouTube. Job Description The Senior Manager, Statistics... ...trials, patient safety, and global medical affairs. The Senior Manager works... ...and documentation. Support regulatory submission and product life-cycle management... ...to asset development. Lead in identifying...SeniorWork experience placement
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior CMC Regulatory Affairs Lead - Global Submissions. Be the first to apply!
Related searches
- senior specialist North Chicago, IL
- international tax senior North Chicago, IL
- senior network engineer remote North Chicago, IL
- senior manager legal North Chicago, IL
- senior performance engineer North Chicago, IL
- remote senior salesforce administrator North Chicago, IL
- senior brand designer North Chicago, IL
- senior software engineer remote North Chicago, IL
- senior business analyst contract North Chicago, IL
- senior consulting engineer North Chicago, IL