GRA Labelling Specialist

Sanofi; Hyderabad; Hybrid; INR 1,400,000 - 2,000,000; Full time

Job summary

Sanofi in Hyderabad (Indien) sucht einen erfahrenen GRA Labelling Specialist zur Bereitstellung und Aktualisierung von Unternehmenskennzeichnungsdokumenten (CCDS, USPI, EU SmPC) für Produkte in Markteinführung und Lifecycle. Sie koordinieren den Labeling-Review-Prozess, arbeiten mit funktionsübergreifenden Teams zusammen, entwickeln globale Labeling-Strategien und bereiten MAH-Antworten vor.

Anforderungen: 6–9 Jahre Erfahrung, Abschluss in Lifesciences, fließendes Business English.

Qualifications

• 6–9 Jahre relevante Industrie- oder Funktions­erfahrung in Regulatory Affairs/Labeling.
• Bachelorabschluss in Lifesciences oder gleichwertig mit 3+ Jahren Erfahrung in Regulatory Affairs/Labeling.
• Fließendes Business-English.

Responsibilities

• Vorbereitung/Aktualisierung von Corporate-Labelling-Dokumenten (CCDS, USPI, EU SmPC) und Patiententext.
• Koordination des Labeling-Reviews und Freigaben im End-to-End-Prozess; Erstellung von Labeling-Komponenten für Behördenanträge.
• Unterstützung funktionsübergreifender Teams als Labeling-Experte und Beitrag zur globalen Regulatory-Strategie.
• Pflege/Reaktion auf Health-Authority-Anfragen (EU/US); Teilnahme an Verhandlungen.
• Leitung multidisziplinärer Labeling-Working-Groups und Präsentation von Vorschlägen.

Skills

Labeling knowledge

Regulatory coordination

Cross-functional collaboration

Project management

Attention to detail

Education

Bachelor’s degree in Lifesciences or equivalent

Job description

GRA Labelling Specialist# Sanofi Careers## GRA Labelling SpecialistBewerben: Hyderabad: Vollzeit: Heute ausgeschrieben: Enddatum: 30. November 2026 (Noch 19 Tage Zeit für Bewerbung): R2869261## **Job title: GRA Labelling Specialist*** ## **Location : Hyderabad, India (Hybrid Model)**## ## **About the job**## ## **Our Team: Drive Labeling Value to maximize Sanofi ́s competitive advantage**## **About the job**## **Our Team: Drive Labeling Value to maximize Sanofi ́s competitive advantage**## **Main responsibilities:*** Prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products for company and/or agency approval.* Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for mature/marketed products.* Support cross-functional teams (LWG) as a labeling expert and contribute to the global regulatory strategy and to the preparation of of labeling components of submission dossiers or responses to Health Authorities...* For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, or work sharing, PRAC questions (signal detection)* Anticipates any hurdles and informs manager as appropriate* Coordinate and create the presentation of labeling proposals to be presented to Senior Executive Management via Labeling Review Committee* Perform labeling competitive/comparator analysis* Meet established submission timelines and quality standard for labeling deliverables* Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling. **About you*** **Experience**: Knowledge of the principles and concepts of Labeling (including generics), and the dynamics of Labeling Team purpose and objectives.* Knowledge of labeling requirements for drugs (CCDS EU, US); organizational and networking skills; and ability to coordinate discussions across a multi-functional group (LWG) to reach resolution on labeling topics.* Ability to read and interpret HA regulations and guidances, and relevant company SOPs.* Ability to connect regulatory strategy into labeling strategy* Ability to work autonomously for routine tasks but needs oversight on more complex topics (as needed)* Ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC...), provide labeling strategy proposal, negotiate, resolve conflict and build consensus.* Must be able to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling* Support local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc...)* **Soft skills**: Excellent written and verbal communication skills, networking skills.* Situational awareness, problem solving skills.* Organizational skills, ability to manage multiple projects at short notice.* Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.* Defined experience requirement: 6–9 years of relevant industry or functional experience.* **Technical skills:** Highly detail oriented, strong analytical and organization skills, project management skills, self-starter, critical thinking required, ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics. Ability to build/learn scientific knowledge (e.g. statistics, disease area).Ability to search for public data on labeling elements (enabling digital capabilities)* **Education**: Bachelor’s degree in Lifesciences or equivalent, with 3 plus years of related work experience in Regulatory Affairs/Labeling or equivalent in highly regulatory environment* **Languages:** Fluent business English.Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.