Manager Regulatory Affairs, Global Regulatory Strategy US & Canada - Hybrid

AbbVie Inc.; North Chicago (IL); Hybrid; USD 120,000 - 165,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Long-term incentive programs

Job summary

AbbVie Inc. in Lake County, IL is seeking a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory planning for US and Canada markets and to align strategy with development and commercialization goals.

You will act as a primary FDA liaison, prepare and review regulatory submissions, advise cross-functional teams, and ensure timely, compliant interactions with health authorities across the lifecycle of assigned products.

Qualifications

• 6 years Regulatory, R&D, or Industry-related experience.
• 2-3 years in pharmaceutical regulatory activities.
• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
• Advanced degree or certifications a plus.

Responsibilities

• Serve as Health Authority liaison with FDA for routine communications in support of filings.
• Support preparation and review of regulatory submissions compliant with US/Canada requirements.
• Provide regulatory guidance to cross-functional teams including Clinical, Legal and Commercial.
• Apply regulatory knowledge to advise on project strategy and approvals.

Skills

Regulatory strategy

FDA liaison

Cross-functional collaboration

Regulatory submissions

Regulatory compliance

Education

Bachelor’s degree in pharmacy/biology/chemistry/pharmacology or industry related

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The Manager Regulatory Affairs, Global Regulatory Strategy US & Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

This individual assists Regulatory Staff by identifying and gathering data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities

• Responsible for a product(s) within a Therapeutic Area and supports the Manager (Senior Manager, Associate Director, Director (Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.
• Assigned matters may have an impact on business activities and operations.
• Serves as Health Authority (HA) liaison with FDA for routine communications in support of filings including complete and timely responses during application review.
• 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.
• 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.
• Applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, 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).

This role will work a hybrid work schedule (3 days in office) from AbbVie Lake County, IL headquarters.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Required Education

Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.

Preferred Education

Advanced Degree a plus. Certifications a plus.

Required Experience

6 years Regulatory, R&D, or Industry-related experience.

Preferred Experience

2-3 years in pharmaceutical regulatory activities

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

Benefits

We offer a comprehensive package of benefits 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 long-term incentive programs.

Note

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Equal Opportunity Employer

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html