Senior Manager, Global Regulatory Strategy, US & Canada

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / Florham Park (Morris County) New Jersey

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.

Key Responsibilities

• Ensure that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs.

• Identify and gather 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.

• Responsible for product(s) with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director, or Director, in the development & execution of the regulatory strategy.

• Serve 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.

• Responsible for negotiations and decision-making for project related issues that have cross-functional impact.

• Assist in the development, training of staff members.

• 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.

• Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs (INDs), Investigational Medicinal Product Dossier (IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs), Quality Overall Summaries (QOS), and Biologics License Applications (BLAs).

• Work on projects for thoroughness, accuracy, and timeliness of CMC dossiers and responses by using electronic documentation management systems (EDMS).

• Responsible for communicating and