Manager Regulatory Affairs, Global Regulatory Strategy US & Canada

Regulatory Toolkit; Chicago (IL); Hybrid; USD 120,000 - 180,000; Full time

Job summary

AbbVie in Lake County, IL is seeking a Manager Regulatory Affairs to lead US & Canada regulatory strategy for on-market products and development programs. The role focuses on planning, data collection, and timely interactions with Health Authorities to support filings and registrations.

You will negotiate with FDA, coordinate cross-functional teams, and ensure submissions meet regulatory guidelines. Hybrid work includes 3 days in office; we seek candidates with 6 years of regulatory or related

Qualifications

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
• 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.
• Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus.
• Experience working in a complex and matrix environment.
• Good communication, both oral and written.
• Experience interfacing with government regulatory agencies.
• Demonstrates good negotiation skills and builds consensus.

Responsibilities

• Develop and execute regulatory strategy for US and Canada.
• Serve as Health Authority liaison with FDA for routine communications.
• Prepare and review regulatory submissions in US/Canada.
• Support regulatory submission and approval processes.
• Apply regulatory knowledge to projects and cross-functional teams.
• Present regulatory information to cross-functional areas.
• Ensure compliance with regulations and the Quality Dossier Program (QDP).

Education

Bachelor’s degree (pharmacy, biology, chemistry, pharmacology)

Advanced Degree

Good communication

Negotiation skills

Interfacing with government regulatory agencies

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 & Canadais 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
• Skill Set:
  • Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus.
  • Experience working in a complex and matrix environment.
• Skill Set cont'd:
  • Good communication, both oral and written.
  • Experience interfacing with government regulatory agencies.
  • Demonstrates good negotiation skills and builds consensus.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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