Associate Director, Regulatory Affairs CMC (Onsite Hybrid)

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

As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC), you will collaborate with both internal and external partners to ensure the successful delivery of products to patients. Your scope of work will include innovative areas such as protein therapeutics, antibody-drug conjugates (ADC), and cell & gene therapies. You will be responsible for creating CMC regulatory strategies that facilitate first-pass approvals of regulatory submissions. This involves developing and managing content strategies for submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), amendments, new marketing applications, and supplements/variations.

In this role, you will build and sustain robust relationships across Regulatory Affairs, Operations, and Research & Development (R&D) functions. You will represent CMC on various teams, including product development, Global Regulatory Product Teams, and Operations brand teams, where you will use your negotiation and influence skills to provide strategic guidance. Additionally, you will act as a strategic liaison with regulatory agencies, such as the FDA, to ensure alignment on CMC matters.

Responsibilities Include:

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, annual reports, supplements and variations and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agen