Purpose:

　　Responsible for the development and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Assures that regulatory strategies are 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 global regulatory requirements.

　　Responsibilities:

　　· Responsible for a product or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, Director, or Senior Director), in the development and 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 and 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, guidance, 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:

　　· Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years’ experience in Regulatory Affairs; or

　　· Education equivalent to a MS degree or equivalent in a scientific field or experience in lieu of, plus at least 6 years’ experience in Regulatory Affairs; or

　　· Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years’ experience in Regulatory Affairs

　　· Demonstrates excellent negotiation skills, problem solving skills and builds consensus

　　· Demonstrates 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

　　· Experience working in a complex and matrix environment. Global regulatory experience is a plus

　　· Experience interfacing with government regulatory agencies

　　· Computer literate with knowledge of EDMS systems for electronic storage and submission. Experience with Adobe Acrobat, MS Office, and ability to learn new computer programs

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.