Senior GRA Labeling Specialist

Overview

Lead labeling strategy and preparation of corporate labeling documents (CCDS, USPI, EU SmPC) and patient text for assigned marketed and lifecycle products, and chair multidisciplinary labeling working groups within Sanofi's Global Regulatory Affairs function.

What you'll do

• Lead labeling strategy and prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and lifecycle management products, including line extensions and dosage form changes, for company and/or agency approval.
• Coordinate labeling review and approval throughout the end-to-end labeling process, including preparation of labeling components for submission to regulatory agencies.
• Participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
• Release labeling for use throughout the company for marketed and lifecycle management products, including complex updates and line extensions.
• Support cross-functional teams as an experienced labeling expert (LWG and GRT) and contribute to the global regulatory strategy and to the preparation of labeling components of submission dossiers or responses to Health Authorities.
• Chair multidisciplinary labeling working groups, present labeling proposals, and develop and reach consensus on proposals for presentation to the Labeling Governance Committee for internal approval.
• Be a member of response teams for maintenance and compliance of existing Marketing Authorizations, including European arbitration/referrals, work sharing, and PRAC questions (signal detection).
• Anticipate hurdles in implementation, inform the manager, and act to minimize them.
• Coordinate, create and present labeling proposals to Senior Executive Management via the Labeling Review Committee.
• Assess relevant study reports, pharmacovigilance data (post-marketing) and other scientific reports required to support labeling proposals.
• Perform labeling competitive/comparator analysis to provide insights.
• Meet established submission timelines and quality standards for labeling deliverables.
• Contribute to transversal or process improvement projects and workstreams across the labeling portfolio.

What you'll need

• Knowledge of the principles and concepts of labeling (including generics, authorized generics, private labels, device/combination products) and the dynamics of labeling team purpose and objectives.
• Demonstrated knowledge of labeling requirements for drugs (CCDS EU, US).
• Organizational and networking skills, and ability to coordinate discussions across multifunctional groups and teams (LWG, GRT) to reach resolution on labeling topics.
• Ability to read and interpret Health Authority regulations and guidance, and relevant company SOPs.
• Strong ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC), provide labeling strategy proposals, negotiate, resolve conflict and build consensus.
• Ability to lead labeling strategy connected to regulatory strategy.
• Ability to work autonomously on most tasks, with oversight on more complex topics (occasional).
• 10–12 years of relevant experience demonstrating advanced capability.
• Exposure to working with Regulatory Affairs, Pharmacovigilance, Medical Affairs, or clinical development.
• Support local countries as global labeling SME (e.g., during labeling negotiation and Health Authority discussions).
• Ability to construct a Company Response (MAH response) for Health Authority (EU/US) questions related to labeling.
• Excellent written and verbal communication skills, networking skills, situational awareness, leadership and problem-solving skills.
• Organizational skills and ability to manage multiple projects at short notice; ability to work with all levels of associates and management (domestic/international).
• Highly detail oriented, strong analytical, organizational and project management skills, self-starter, critical thinking, and strong ability to network and coordinate discussions across all levels of the company.
• Ability to build/learn scientific knowledge (e.g., statistics, disease area) to work across therapeutic areas.
• Ability to search public data on labeling elements (enabling digital capabilities).
• Bachelor's degree in a scientific discipline, or relevant/equivalent, with 5 years of experience in Regulatory Affairs (including 2 years direct labeling experience) or equivalent in a highly regulated environment.
• Fluent business English.

Details

• Location: Hyderabad, India.
• Work mode: Hybrid.