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