Director, Regulatory Affairs, Strategic Global Labeling (Neuroscience)

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Job description

Job Description

The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). Collects and analyzes labeling issues and trends that affect the business. Possesses and leverages solid understanding of labeling regulations, opinions and guidances of regulatory authorities, political and legal climate and industry practices to ensure that organizational goals are met. Operates independently with recognition of when to consult upper management concerning potential risk. Establishes labeling policy compliant with changing regulatory environment. Manages labeling staff for assigned therapeutic area(s).

Responsibilities

Develops and directs regulatory labeling strategy planning for or across assigned product group and ensures labeling strategies are in-line with business needs. Presents process, strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings (Global Regulatory Forum (GRF), Executive Labeling Committee (ELC), Steering Committee)

Leads cross functional labeling teams including regulatory, clinical and safety. Manages labeling history and negotiation documentation for assigned products. Provides labeling strategy and direction to teams involved in agency activities. Leads resolution for labeling issues

Ensures that agreed regulatory strategies or commercial concepts are efficiently implemented in labeling documents, and that labeling strategies are maintained in-line with changing regulatory and business needs. Ensures labeling documents meet R&D and commercial needs

Develops and implements internal and/or external strategies to proactively influence legislation/ guidelines with impact on AbbVie business, and to address changes in the regulatory environment. Represent company with regulatory agencies on labeling policy topics. May represent company at inspection activities for labeling topics

Ensures standard interpretation of regulations across projects.

Develops and manages an effective team. Conducts succession planning. Manages the work of direct reports. Trains new personnel and provides input to new department processes/policies

Represents company at external labeling meetings with partner companies or industry associations

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