Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie
Senior Manager leading US and Canada regulatory strategy development and implementation for AbbVie's marketed and development-stage products. Serves as FDA liaison, prepares regulatory submissions, and advises cross-functional teams on compliance requirements.
Responsibilities
- Develop and execute regulatory strategies for assigned product(s) across therapeutic areas
- Serve as liaison with FDA, coordinate briefing packages, and manage regulatory submissions
- Prepare and review regulatory submissions meeting US and Canada requirements
- Advise internal stakeholders including Clinical, Legal, and Commercial on regulatory matters
- Recommend and implement regulatory changes based on government guidance and corporate policy
Requirements
- Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field
- Minimum 6 years regulatory affairs, R&D, or pharmaceutical industry experience
- At least 2–3 years performing pharmaceutical regulatory activities
- Strong negotiation, problem-solving, and consensus-building skills
- Excellent written and oral communication across regulatory and organizational functions
- Proven experience implementing US and Canada regulatory strategies
- Experience in complex, matrix organizational environments
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada in North Chicago, IL vacancy
- ...portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the development and...SeniorWork at officeLocal areaRemote work
- ...information about AbbVie, please visit us at . Follow @abbvie on... ...Instagram , X and YouTube. The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is responsible... ...strategies defined within the Global Regulatory Product Team (GRPT), are...Senior
- ...AbbVie seeks a Senior Manager of Regulatory Affairs to lead US and Canada regulatory strategy for aesthetics devices. The role involves developing and implementing regulatory plans for marketed and pipeline products, managing FDA interactions, and supporting cross-functional...Senior
AbbVie
North Chicago, IL2 days ago - ...information about AbbVie, please visit us at . Follow @abbvie on LinkedIn,... .... Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible... ...strategies defined within the Global Regulatory Product Team (GRPT), are...SeniorFull timeLocal area
- AbbVie is seeking an experienced Regulatory professional to lead US/Canada regulatory strategy and lifecycle activities for on-market and development... ...outcomes. You will collaborate with Global Regulatory Product Teams, manage complex regulatory projects in a matrix environment...Senior
- ...Senior Manager in regulatory affairs overseeing US advertising and promotion compliance at a pharmaceutical company. The role combines scientific and regulatory... ...Develop and implement promotional activity strategies across therapeutic areas Manage and mentor direct...Senior
AbbVie
North Chicago, IL5 days ago - ...Director-level regulatory affairs role leading global strategy development and market approval efforts for neuroscience products. Manages cross-functional teams, regulatory dossiers, and lifecycle... ...including drug development in US and other regions ~5+ years strategic...
AbbVie
North Chicago, IL5 days ago - ...AbbVie, please visit us at Follow @... ...The Director Regulatory Affairs Global Regulatory Lead (... ...Global Regulatory Strategy, is responsible for... ...regulatory requirements. Manages compounds through... ...documentation of reg strategies.... ...objectives established by senior management....Local areaWorldwide
- ...information about AbbVie, please visit us at Follow @abbvie on LinkedIn,... ..., X and YouTube. Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion combines... ...Development and guides implementation strategies for promotional activities Broadly applies...SeniorWork at officeRemote work
- ...Capital One seeks a Senior Director, Data Scientist... ...science efforts for the Global Payment Network. You will mentor teams, shape strategy, and drive ML solutions... ...with engineers, product managers, and analysts to deliver... ...payment networks. #J-18808-Ljbffr Jobleads-USSenior
$165k - $185k
...your hard work? Lundbeck is a global biopharmaceutical company... ...and transform lives. Join us on our journey of growth!... ...States SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the creation... ...perspective at Regulatory Affairs Focus Team (RAFT) meetings....SeniorWork at officeRemote workFlexible hoursLundbeck
Deerfield, ILmore than 2 months ago- ...CDW is seeking a Senior Manager of Compensation to lead global compensation programs, including long-term incentives, executive and broad-base pay. You will... ...data-driven outcomes while ensuring compliance and equity across the organization. #J-18808-Ljbffr Jobleads-USSenior
- ...AbbVie seeks a Senior Director of Manufacturing Strategy to shape global manufacturing strategy across ME&C sites and drive efficiency, innovation, and alignment... ...demands 15+ years in manufacturing operations or related leadership in pharma. #J-18808-Ljbffr Jobleads-US
$123k - $205.1k
...Position Details: As the Senior Manager of Export and... ...regulations across our global operations. You will lead... ...company's risk profile and regulatory requirements. Function... ...assessments. Develop strategies to mitigate identified... ..., please advise us so that we can provide...SeniorFull timeWork at officeLocal areaWorldwide3 days per weekGrainger
Lake Forest, IL1 day ago$206.5k - $393k
...AbbVie, please visit us at . Follow @abbvie... ...Purpose: The Senior Director, Manufacturing Strategy plays a pivotal role... ...the organization's global manufacturing operations... ...manufacturing plans. Manage the ME&C site... ...industry trends and regulatory requirements to maintain...Senior- ...Description Miami or Orlando, FL \n \n Our client is a Brazil/US legal and business advisory firm that helps multinational... ...Brazilian companies on moving executives and teams to the US, from strategy to approval. \n - Act as trusted counsel to founders,...SeniorPermanent employmentH1bWork at office
NAGY Consulting
Mundelein, IL2 days ago $126k - $175k
...and information-management systems, we apply... ...quality of life on a global scale. Our agile,... ...a Sr Manager, Regulatory Affairs & Quality Assurance... ...Robotics. The Senior Manager position... ...leads the regulatory strategy for new and... ...authorities in the US & Canada. The individual is...SeniorWork at officeWorldwideSysmex
Lincolnshire, IL4 days ago$124.2k - $207k
...time, consistent with applicable law. Position DetailsThe Senior Manager, Corporate Strategy serves as a key partner in developing and refining Grainger... ...part of the application, interview or hiring process, please advise us so that we can provide appropriate assistance.SeniorFull timeLocal areaWorldwide2 days per week3 days per weekGrainger
Lake Forest, IL8 hours ago- ...AbbVie, please visit us at . Follow @abbvie... ..., X and YouTube. The Senior Manager, Regulatory Strategic Planning, is... ...across the Regulatory Affairs organization. The... ...AbbVie’s regulatory strategies. The Senior Manager will... ...deliverables for the Global Regulatory Product Teams...SeniorWork at office
- 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
- ...Chicago, IL. 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...Senior
- AbbVie seeks a leader to oversee publications across assigned assets, driving plans and cross-functional execution. You will manage manuscripts, abstracts, posters, and talks to align with strategic goals and policies. You will mentor staff, collaborate with scientific...Senior
$200.7k - $229.1k
...Senior Business Manager, Fraud Operations StrategyThe Senior Business Manager of Fraud Operations Strategy will lead a high-performing team of data science... ...dedicated to protecting the global payment network. This... ...any position posted in Canada is for Capital One Canada...SeniorFull timePart timeLocal areaCapital One
Deerfield, IL2 days ago- ...AbbVie, please visit us at Follow @abbvie... ...innovation, regulatory landscape, and AbbVie... ...s evolved business strategy are complex, rapid... ...development programs. Senior Manager, Safety, Medical &... ...management of a RDQA global Safety, Regulatory Affairs (RA) or Medical Affairs...SeniorWorldwide
- ...AbbVie, please visit us at . Follow @abbvie... ...HEOR) scientists with global responsibility for demonstrating... ...across TA worldwide management and senior leadership of the... ...to the VP HEOR Strategy Franchise, the Sr. Director... ...ethical, scientific, regulatory, commercial, and...SeniorFull timeWork experience placementLocal areaWorldwide
AbbVie Inc.
Mettawa, ILmore than 2 months ago - ...portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube. Job Description The Senior Manager, Process Excellence within Regulatory Affairs , is responsible for managing key process excellence...SeniorWork at officeRemote work
- ...AbbVie, please visit us at . Follow @... ...overall commercial strategy of the PCS oncology... ...successful global product launches... ...with Global Medical Affairs, Pharma Development... ...opportunity and issue management at strategic and... ...will present to senior leaders on a...Full timeLocal area
AbbVie Inc.
North Chicago, ILa month ago - ...in Lincolnshire, IL, seeks a Senior Patent Attorney to lead the IP strategy and patent portfolio across global markets. You will work with engineers... ...relevance. You will manage outside counsel, advise... ...years of patent experience; a #J-18808-Ljbffr Jobleads-USSenior
- AbbVie is looking for a senior leader in North Chicago... ...oversee the commercial strategy of its oncology assets.... ...product launches in a global context. Ideal candidates... ...of leadership and P&L management. The position offers a... ...and a 401(k) plan. Join us to drive innovation and...
- ...Job Description Director, Regulatory Affairs (Global Regulatory Advertising and... ...experience leading or facilitating US promotional review... ...functional teams on promotional strategy, claims development, fair balance... ...and risk mitigation. \n Manage all submissions to FDA...Work at officeLocal area
ALKU
Mundelein, IL4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada. Be the first to apply!
Related searches
- training and compliance manager North Chicago, IL
- director global regulatory affairs North Chicago, IL
- head compliance North Chicago, IL
- senior regulatory manager North Chicago, IL
- regulatory manager North Chicago, IL
- manager regulatory affairs North Chicago, IL
- compliance manager North Chicago, IL
- regulatory affairs manager pharmaceutical North Chicago, IL
- regulatory affairs director North Chicago, IL
- senior director regulatory affairs North Chicago, IL