Manager Regulatory Affairs, Global Reg Strategy US & Canada

Manager Regulatory Affairs, Global Reg Strategy US & CanadaThe Manager Regulatory Affairs, Global Reg 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. The Manager 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. The Manager advises on US/C region specific requirements and assesses R&D programs against region specific 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 position will work a hybrid schedule (3 days in office) from our Lake County, IL AbbVie headquarters.Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is requiredQualificationsRequired 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 activitiesSkill 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.Additional InformationThe 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.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 short-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.US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.htmlRecruitment Fraud AlertAbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.Protect yourself by verifying job offers and communications. Your safety is important to us.Pay Range: $109500 - 208500 USDWhere We WorkRole is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.