Senior GRA Labeling Specialist

About the Role

We are seeking a Senior GRA Labeling Specialist based in Hyderabad, India, to lead labeling strategies that enhance Sanofi's competitive position. This role involves preparing and updating key corporate labeling documents such as CCDS, USPI, and EU SmPC, along with patient text for marketed and lifecycle products, including line extensions and dosage forms. The candidate will manage the complete labeling process, from document preparation and review through regulatory submissions and approvals, supporting multifaceted product launches and modifications.

Key Responsibilities

• Take charge of labeling strategy development and oversee the creation, revision, and approval of labeling documents for various products.
• Coordinate end-to-end labeling review and approval, including compiling submission components and representing the company in regulatory negotiations.
• Act as an expert resource to cross-functional teams (Labeling Working Groups and Global Regulatory Teams), contributing to global regulatory strategy and submission dossier preparations.
• Lead multi-disciplinary labeling working groups to present proposals, drive consensus, and secure internal approvals via the Labeling Governance Committee.
• Participate in compliance and maintenance activities for existing Marketing Authorizations, including involvement in European Arbitration, referrals, and responding to pharmacovigilance inquiries.
• Predict and mitigate potential challenges in labeling implementation, notifying management and taking proactive actions.
• Create and deliver labeling proposals to Senior Executive Management through the Labeling Review Committee.
• Analyze study reports, pharmacovigilance data, and other scientific findings to support labeling decisions.
• Conduct competitive labeling analysis to inform strategy.
• Ensure timely delivery of labeling materials that meet quality standards.
• Contribute actively to cross-cutting process improvements and project workstreams within the labeling portfolio.

Qualifications and Skills

• Extensive understanding of labeling principles and concepts, including generics, authorized generics, private labels, and device/combination products.
• Demonstrated knowledge of drug labeling compliance for US and EU markets, with strong organizational and networking aptitude.
• Proficient in interpreting regulatory authority regulations, guidance, and company SOPs related to labeling.
• Leadership capability to guide multidisciplinary groups comprising Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, preclinical, and CMC teams to develop and agree on labeling strategies.
• Experience aligning labeling strategies to overarching regulatory plans.
• Ability to operate independently on most tasks, seeking oversight only on complex matters.
• A minimum of 10 to 12 years of relevant experience with advanced expertise.
• Exposure to cross-functional work with Regulatory Affairs, Pharmacovigilance, Medical Affairs, or clinical development teams.
• Proven skills in handling regulatory labeling negotiations and health authority discussions.
• Capability to draft authoritative company responses to regulatory queries concerning labeling for EU and US authorities.
• Excellent written and verbal communication skills, along with strong networking and interpersonal abilities.
• Situational awareness, problem-solving aptitude, organizational skillset to handle multiple projects simultaneously with short notice.
• Detail-focused with strong analytical thinking, project management capabilities, critical thinking, and initiative-taking mindset.
• Technical aptitude for acquiring scientific knowledge, such as statistics and disease areas, to work effectively across therapeutic fields.
• Digital savvy, able to source public data for labeling components.
• Educational background: Bachelor's degree in a scientific discipline or equivalent, coupled with 5 years relevant regulatory affairs experience, including a minimum of 2 years directly in labeling or comparable regulated environment.
• Fluent business English proficiency is required.