Associate Director, RA CMC Pipeline (Hybrid Onsite)

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including new marketing applications, supplements and variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research and Development groups. Manages products and change controls in compliance with regulations and company policies and procedures. Represents CMC on teams such as Product Development, Global Regulatory Project Teams and Operations teams to negotiate, influence, and provide strategic advice. Serves as liaison and strategic partner with FDA. Manages assigned projects within assigned resources. May manage, coach, mentor, and develop junior staff, including new employee onboarding.

Responsibilities:

• Prepares CMC regulatory product strategies. Seeks expert advice, regulatory intelligence and technical support as required for strategies and submissions
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of briefing documents
• Regularly informs regulatory management of important timely issues
• Manages preparation of CMC submissions. Prepares and manages regulatory applications, including new applications and amendments, renewals, annual reports, supplements and variations
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
• Identify and communicate content gaps and risks for submissions
• Manages change c