Senior RA CMC Strategy Lead — Global Submissions
AbbVie
AbbVie is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to partner with internal and external teams to deliver products to patients. You will develop regulatory strategies for CMC to enable first-pass approvals and manage content for INDs/CTAs, supplements, and variations. You will collaborate across RA, Operations and R&D and interface with regulatory agencies. #J-18808-Ljbffr AbbVie
- ...Instagram , X and YouTube. Job Description The Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME is responsible for oversight of... ...SME, this individual provides training and advice to RA colleagues on FDA regulatory policy interpretation and...SeniorFull timeLocal areaImmediate start
- ...and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is... ...strategies defined within the Global Regulatory Product Team (GRPT),... ...preparation and review of regulatory submissions consistent within US and Canada...Senior
- ...YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is... ...and supports manager and/or Global Regulatory Lead (GRL) in the development... ...and review of regulatory submissions consistent within US and Canada...SeniorLocal area
- AbbVie seeks an Associate Director for CMC Portfolio Management to lead development and maintenance of CMC... ...for Product Presentation & Device Strategy Teams. You will coordinate with R&D/... ...collaboration, and strategic representation to senior leaders. #J-18808-Ljbffr BioSpaceSenior
- ...Initiatives within Clinical Development Operations to lead high-priority, enterprise initiatives from... ...value across cross-functional teams in a global matrixed organization. As a strategic thought partner, you will shape strategy, establish funding, and ensure execution...Senior
- ...organization that includes CMC (Process R&D, Drug Product Development... .... The Data & Digital Strategy CORE team within Development... ...Director, Strategy Lead for Submission Automation is responsible for... ...position reports directly to the Senior Director, Development Sciences...Full timeLocal area
- AbbVie in the United States is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for drug products. You will collaborate with internal teams and external partners, negotiating with agencies to enable first-pass approvals...
- AbbVie is seeking an Associate Director, Strategy Lead for Submission Automation within Development Sciences Data & Digital Strategy. Hybrid role in Lake County, IL or Worcester, MA, reporting to the Senior Director and potentially leading a small team. You will shape the...
- AbbVie is seeking a Strategy Lead for Submission Automation in the Development Sciences Data & Digital Strategy group. You will shape the business strategy, roadmap, and cross-functional execution for automation of dossier submission reporting (INDs/BLAs) across modalities...
- AbbVie is seeking an Associate Director, Strategy Lead for Submission Automation to shape the automation roadmap for dossier submissions across modalities. You will partner with dossier management, Development Sciences, Regulatory Affairs, and IT to translate reporting...
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid). You will develop and execute regulatory strategy and tactics for US/Canada, coordinating with FDA to ensure timely filings and inspections and enabling...
- ...Description The Senior Manager Regulatory... ...and Controls (CMC) works with internal... ...CMC regulatory strategies that enable first... ...strategy for regulatory submissions, including INDs/... ...development, Global Regulatory Product... ...initiatives internal to RA CMC. Represents...SeniorWork at officeLocal areaRemote work
- ...YouTube. Job Description The Senior Regulatory Associate, Regulatory Affairs, Strategic Global Labeling- Operations assists with... ...Strategic Global Labeling and submission teams to provide appropriate... ...experience in a regulatory affairs strategy role preferred. Note: Higher...SeniorTemporary work
- Uline is seeking a Senior Corporate Recruiter to lead full lifecycle recruiting for critical corporate roles, mentor a recruiting team, and shape talent strategy to support our growth. The role emphasizes complex assignments, sourcing top talent, and partnering with HR...Senior
$129.3k - $258.7k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps... ...the spectrum of healthcare, with leading businesses and products in diagnostics... ....The OpportunityWe are seeking a Senior Global Marketing Manager, Upstream Strategy, Innovation and Product Management...SeniorLocal areaWorldwideShift work- AbbVie in North Chicago, IL, is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL I) to develop and implement global regulatory strategies for assigned therapeutic areas. You will lead the Global Regulatory Product Team (GRPT), coordinate with US/Canada...
$165k - $185k
...hard work? Lundbeck is a global biopharmaceutical company... ...States SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the creation... ...intended for regulatory submissions for accuracy and compliance... ...and the Global Regulatory Lead, serves as US subject...SeniorWork at officeRemote workFlexible hours- Buehler An ITW Company in Lake Bluff seeks a Senior Manager, Global Product Management to lead the strategy and lifecycle management of its product portfolio. This role combines strategic and hands-on execution to optimize product development and profitability. The ideal...
- AbbVie seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. The role involves shaping regulatory plans... ...interfacing with FDA, coordinating submissions, and guiding cross-functional... ...skills, with experience in global regulatory activities and...
- AbbVie seeks a Director of Environmental Health and Safety to lead global EHS strategy, drive regulatory compliance, risk management, and incident... ...will develop and mentor EHS professionals, partner with senior leaders to embed safety and sustainability into operations,...
- A leading biopharmaceutical company in North Chicago is seeking a Senior Counsel - Intellectual Property Litigation. This role requires management of global patent litigation and related disputes, providing expert counsel to clients, and participation in various litigation...Senior3 days per week
- ...This role involves providing legal guidance on intellectual property matters, drafting patent applications, and managing the patent strategy. The ideal candidate will have a JD degree, at least 8 years in patent law, and a technical background in pharmaceuticals. AbbVie...Senior
- ...Description The Senior Associate, RA CMC is responsible for ensuring... ...preparation of submission documents. The Senior... ...with RA CMC Project Leads to create and develop... ...content plans, bundling strategies, and project... ...levels and types of global personnel required...SeniorFull timeTemporary workWork at officeLocal areaRemote work
- AbbVie in North Chicago seeks a Senior FP&A professional to provide financial planning and analysis support to Global BTS. You will manage actuals, plan, LBEs and LRP, delivering insights to VPs and BMO. The role involves budget scope of 700MM+ and 800+ headcount, and partnership...Senior
- ...Regulatory Affairs professional to support global and US registrations for device products.... ...analyze requirements, create regulatory strategies, and maintain dossiers with oversight.... ...years in medical products, strong ability to lead regulatory arguments, and experience...Senior
- A global staff augmentation firm is seeking a Senior Regulatory Affairs professional to oversee drug product development and compliance. This role requires... ...health authorities, and strategic planning for submissions. Join a dynamic team aiming for mutual growth and innovation...Senior
- Uline, North America's leading distributor of shipping, industrial, and packaging materials, is seeking a Senior International Trade Compliance Specialist to optimize import/export... ...and help drive compliance programs across global shipments. On-site opportunities at...Senior
$129.3k - $258.7k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps... ...spectrum of healthcare, with leading businesses and products in... ...and execution of global HEOR strategies, ensuring effective... ...and influencing skills with senior internal and external stakeholdersPreferred...WorldwideShift work- AbbVie is seeking a seasoned professional to manage outsourced analytical work as the single point of contact for internal teams and external providers. You will coordinate, plan, monitor, and archive GMP-related analyses and work with multiple sites to standardize processes...Senior
- AbbVie is seeking a senior Clinical Pharmacology Scientist to drive PK/PD strategy across Phase 1-4 programs and lead methodological advances in pharmacometrics. You will partner... ...cross-functional teams to craft regulatory submissions and scientific publications. The role...Senior
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