Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid Onsite)

Job Opportunity At 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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

We are looking for a professional to develop and implement US and Canada regulatory strategic and tactical planning for assigned on market products or those products in development. This position will support the Neuroscience therapeutic area.

Responsibilities include :

• 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.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• 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 with US and Canada regulatory requirements and guidelines.
• 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).

This is an onsite hybrid opportunity based in AbbVie's Lake County, IL or Cambridge, MA offices.

Qualifications :

The 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.

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.