AbbVie
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid)
AbbVie, North Chicago, Illinois, us, 60086
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid)
The Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on‑market or in‑development products. The role ensures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. The Senior Manager identifies and gathers data needed to support filings, responds to inquiries, and maintains registrations to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.
Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care—and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Base Pay Range $121,000.00/yr - $230,000.00/yr
Job Description The Senior Manager supports the Manager (Global Regulatory Lead, Associate Director, or Director) in the development and execution of the regulatory strategy for a product or multiple driver indications within a therapeutic area. Responsibilities include building regulatory planning documents, coordinating FDA meetings, negotiating with health authorities, and ensuring timely, complete regulatory submissions in line with US and Canada regulatory requirements.
Responsibilities
Oversee a product or multiple driver indications within a therapeutic area and support the Manager in the development & execution of the regulatory strategy.
Act as the HA liaison and interface with FDA for meetings and teleconferences, coordinating preparation of FDA meeting briefing packages and responses.
Make independent negotiation and decision‑making for project‑related issues with cross‑functional impact, and assist in staff training.
Prepare and review regulatory submissions, ensuring timely, complete responses to Health Authorities during review.
Support the regulatory submission and approval process, applying regulatory and technical knowledge across therapeutic areas.
Recommend and implement changes to difficult projects based on expertise and accurate interpretation of US and Canada government regulations, guidance, corporate policies, and management considerations.
Present pertinent regulatory information to appropriate cross‑functional areas.
Operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications
Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or related field.
Preferred Education: Advanced degree or certifications.
Required Experience: 6 years of regulatory, R&D, or industry‑related experience.
Preferred Experience: 2‑3 years in pharmaceutical regulatory activities.
Demonstrates excellent negotiation and problem‑solving skills, building consensus.
Demonstrates effective written and oral communication skills within Regulatory and across the organization.
Able to deliver challenging messages effectively without compromising business relationships.
Proven skill at implementing successful US and Canada regulatory strategies; experience working in a complex matrix environment.
Global regulatory experience and interfacing with government regulatory agencies is a plus.
Additional Information
The compensation range described reflects the base pay that AbbVie believes in good faith it will pay for this role based on the job grade. Individual compensation may vary.
We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
This job is eligible to participate in our short‑term and long‑term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer – Veterans/Disabled.
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Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care—and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Base Pay Range $121,000.00/yr - $230,000.00/yr
Job Description The Senior Manager supports the Manager (Global Regulatory Lead, Associate Director, or Director) in the development and execution of the regulatory strategy for a product or multiple driver indications within a therapeutic area. Responsibilities include building regulatory planning documents, coordinating FDA meetings, negotiating with health authorities, and ensuring timely, complete regulatory submissions in line with US and Canada regulatory requirements.
Responsibilities
Oversee a product or multiple driver indications within a therapeutic area and support the Manager in the development & execution of the regulatory strategy.
Act as the HA liaison and interface with FDA for meetings and teleconferences, coordinating preparation of FDA meeting briefing packages and responses.
Make independent negotiation and decision‑making for project‑related issues with cross‑functional impact, and assist in staff training.
Prepare and review regulatory submissions, ensuring timely, complete responses to Health Authorities during review.
Support the regulatory submission and approval process, applying regulatory and technical knowledge across therapeutic areas.
Recommend and implement changes to difficult projects based on expertise and accurate interpretation of US and Canada government regulations, guidance, corporate policies, and management considerations.
Present pertinent regulatory information to appropriate cross‑functional areas.
Operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications
Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or related field.
Preferred Education: Advanced degree or certifications.
Required Experience: 6 years of regulatory, R&D, or industry‑related experience.
Preferred Experience: 2‑3 years in pharmaceutical regulatory activities.
Demonstrates excellent negotiation and problem‑solving skills, building consensus.
Demonstrates effective written and oral communication skills within Regulatory and across the organization.
Able to deliver challenging messages effectively without compromising business relationships.
Proven skill at implementing successful US and Canada regulatory strategies; experience working in a complex matrix environment.
Global regulatory experience and interfacing with government regulatory agencies is a plus.
Additional Information
The compensation range described reflects the base pay that AbbVie believes in good faith it will pay for this role based on the job grade. Individual compensation may vary.
We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
This job is eligible to participate in our short‑term and long‑term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer – Veterans/Disabled.
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