Senior Regulatory Affairs Associate- Labeling Strategy

Accountabilities:

• Global Labeling Strategy and Documentation: Develop, maintain, and update global labeling documents, including Company Core Data Sheets (CCDS), United States Prescribing Information (USPI), and regional labels, ensuring alignment with requirements in the United States, European Union, Switzerland, Canada, Australia, and other markets.

• Regulatory Compliance and Lifecycle Management: Manage post-approval labeling activities, including artwork updates, safety variations, xEVMPD submissions, and Periodic Safety Update Reports (PSURs), in accordance with applicable regulations and recommendations from PRAC and CMDh.

• Regulatory Impact Assessments: Evaluate change-control requests affecting medicinal products in registered markets and assess their implications for labeling and regulatory compliance.

• Artwork Coordination and Approval: Coordinate the review and approval of printed packaging components, ensuring compliance with regulatory and design requirements for new products, packaging formats, and artwork changes.

• Structured Product Labeling (SPL): Manage SPL-related activities, troubleshoot technical issues, and oversee labeling document reviews and approvals within document management systems.

• Artwork Workflow Management: Monitor artwork change requests, coordinate artwork creation and translation processes, and maintain accurate artwork trackers and associated systems.

• Comparator Labeling and Regulatory Reporting: Research and prepare comparator labeling documents to support global alignment and competitive analysis, and author labeling components of annual regulatory reports.

• Cross-Functional Collaboration: Work with internal and external stakeholders across regions to coordinate labeling updates and ensure accurate, timely implementation of regulatory changes.

• Process Quality and Documentation: Maintain high standards of accuracy, consistency, traceability, and compliance across labeling documents, submissions, and supporting records.

Requirements:

• A bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field, or equivalent professional experience.

• 7–8 years of experience in pharmaceutical regulatory affairs, with demonstrated expertise in labeling development, regulatory documentation, and post-approval activities.

• In-depth knowledge of labeling regulations and guidelines across major markets, including the United States, European Union, Switzerland, Canada, and Australia.

• Hands-on experience with CCDS-related submissions, safety variations, labeling lifecycle management, and packaging artwork coordination.

• Proficiency in Structured Product Labeling (SPL), including document preparation, review, and troubleshooting.

• Experience using regulatory documentation and document management systems to manage labeling reviews, approvals, and submissions.

• Strong understanding of regulatory compliance requirements and the ability to assess the impact of product changes across registered markets.

• Excellent written and verbal communication skills, with the ability to coordinate effectively across international and cross-functional teams.

• Strong attention to detail, analytical thinking, organizational skills, and problem-solving capabilities.

• The ability to manage multiple priorities, coordinate complex regulatory activities, and consistently deliver accurate work within required timelines.

Preferred qualifications:

• A master's degree in Regulatory Affairs or a related discipline.

• Experience with regulatory information management and labeling systems such as Veeva, TVT, or Docubridge.

• Knowledge of regulations governing pharmaceutical advertising and promotional materials.

• Experience managing labeling activities across multiple therapeutic areas.

Benefits:

• Remote work: Remote working arrangement based in India.

• Professional development: Opportunities to deepen expertise in global regulatory affairs, labeling strategy, and pharmaceutical lifecycle management.

• International collaboration: Work with cross-functional teams supporting regulatory activities across multiple global markets.

• Career growth: Opportunities to expand technical knowledge and contribute to regulatory strategy and product lifecycle activities.

• Meaningful impact: Help maintain the accuracy and compliance of pharmaceutical labeling that supports the safe use of medicines and patient access to treatments.