AbbVie · 3 days ago
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid)
North Chicago, IL
Full-time
Hybrid
Senior Level
$121K/yr - $230K/yr
6+ years expAbbVie is a company focused on discovering and delivering innovative medicines and solutions for serious health issues. The Senior Manager, RA Global Regulatory Strategy US and Canada is responsible for developing and implementing regulatory strategies for products in the US and Canada, ensuring compliance with regulatory requirements and facilitating communication with health authorities.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations
Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses. Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial
Functions independently in negotiation and decision-making for project related issues that have cross-functional impact. Assists in the development and training of staff members
Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas
Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations
Presents pertinent regulatory information to appropriate cross-functional areas
Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP)
Qualification
Required
Bachelor's degree (pharmacy, biology, chemistry, pharmacology) or industry related
6 years Regulatory, R&D, or Industry-related experience
Demonstrates excellent negotiation skills, problem solving skills and builds consensus
Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization
Able to deliver challenging messages effectively without compromising important business relationships
Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies
Experience working in a complex and matrix environment
Preferred
Advanced Degree a plus
Certifications a plus
2-3 years in pharmaceutical regulatory activities
Global regulatory experience is a plus
Experience interfacing with government regulatory agencies
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-09
2026-01-09
Company data provided by crunchbase