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Allergan Aesthetics, an AbbVie Company · 4 weeks ago

Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid)

North Chicago, IL

Full-time

Hybrid

Mid, Senior Level

$121K/yr - $230K/yr

6+ years exp

Allergan Aesthetics, an AbbVie Company, is seeking a Senior Manager for RA Global Regulatory Strategy for the US and Canada. The role involves developing and implementing regulatory strategies for products in the market or in development, ensuring compliance with US and Canada regulations, and serving as a liaison with health authorities.

BeautyManufacturingPharmaceuticalWellness

Responsibilities

Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations

Serves 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

Functions independently in negotiation and decision-making for project related issues that have cross-functional impact. Assists in the development and training of staff members

Key contributor 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

Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas

Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations

Presents pertinent regulatory information to appropriate cross-functional areas

Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP)

Qualification

Regulatory strategyRegulatory submissionsNegotiation skillsPharmaceutical regulatory activitiesGlobal regulatory experienceBuilding consensusProblem solvingEffective communication