Senior Manager, U.S. Regulatory Strategy

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

Description

The Sr Manager Regulatory Affairs represents US regulatory affairs for device development projects.

Responsible for development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team.

Plans and prepares (or oversees) complex regulatory submission documents primarily for US regulatory filings, ensures technical accuracy, and regulatory compliance. Ensures that applications are executed appropriately and submitted on time.

Directs communication and interactions with FDA, as primary contact for the related projects.

Utilizing detailed, in-depth understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.

Duties and Responsibilities:

• Represents US Regulatory in project teams. Develops US regulatory filing strategy, with minimal supervision. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives.
• Works collaboratively with GRL/regulatory/cross functional team to resolve complex project issues.
• Utilize US device regulatory expertise and extensive knowledge of requirements to strategically interpret, plan, and communicate with the team.
• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
• Ensures planned device development activities comply with US regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.