Regulatory Affairs Specialist

Detalles de la oferta

.Company DescriptionAbbVie'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.Job DescriptionThe Specialist, Regulatory Affairs Area, develops and executes regulatory strategies in alignment with Global and Affiliate Regulatory colleagues as appropriate. S/he represents Area on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and properly maintain regulatory applications to Health Authorities across the Area. This role also interfaces with partner functions (e.G., Commercial, Market Access, Quality Assurance) to ensure Regulatory strategies are aligned with business objectives.Major Responsibilities:Provides strategic direction to support the development of compliant and competitive Regulatory programs; Manages the preparation and review of regulatory submissions consistent with Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; Effectively incorporates country-specific regulatory requirements, guidance, and other relevant regulatory intelligence into Regulatory submissions across the Area; Interacts with GRPTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updateson progress and/or issues that may impact the global program; Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area; Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise business objectives; Represents Areaon process improvement initiatives of low- to medium-complexity; is able to represent the needs of Area and Affiliates as appropriate; Leads team meetings effectively; appropriately escalatesand drives issues to resolution; demonstrates good negotiation skills, effective group facilitation skills, and ability to drive consensus among team members; Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential deliverables for a variety of audiences; Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.QualificationsRequired Education:Bachelor's degree in pharmacy, biology, chemistry, pharmacology, etc.Preferred Education:Advanced degree(s); English and Spanish are required. Portuguese fluency is preferred


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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