Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)

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 Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg 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 products or those products in development. They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers 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) 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, 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, 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). Qualifications Minimum Qualifications Bachelors degree (pharmacy, biology, chemistry, pharmacology or related) 6 years Regulatory, R&D, or Industry‑related experience. Experience working in a complex and matrix environment. Experience interfacing with government regulatory agencies. Preferred Qualifications 2-3 years in pharmaceutical regulatory activities Global regulatory experience is a plus. Advanced Degree a plus Certifications a plus Other Required Skills Excellent negotiation skills, problem solving skills and builds consensus. 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. Additional Information 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 thisposting 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 formofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr BioSpace