Regulatory Labeling Strategy Lead

Profile

Regulatory Labeling Strategy Lead

The candidate will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D. With minimal supervision, the Regulatory Labeling Strategy Lead, PDT BU is responsible for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function (Company Core Data Sheets (CCDSs) and global labelling, i.e., US and EU (CP, MRP, and DCP) for PDT BU products). Ensures that there is strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans. Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information. Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance. Drives labeling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels. Formulates and implements innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion. Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders. Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies. Provides guidance on combination product/drug-device labeling. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Introduces creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities. Prepares backup strategies in support of labeling negotiations. Takes initiative in leading global labeling team and cross-functional projects. Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy. Effectively identifies and resolves conflicts/issues to reach labeling decisions with minimal escalation to management for dispute resolution. Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products. Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.

Company info

Shire.
700 Main Street
Cambridge
Massachusetts
United States 02139
Website : https://www.shire.com