Regeneron Hiring Pharmacy Graduates | Regulatory Affairs Role
A rare chance has emerged for professionals in the regulatory affairs sector. This Regeneron Regulatory Affairs Job is for a Regulatory Affairs Labeling Specialist to join the team in Hyderabad, India. This role involves supporting global regulatory labeling activities and ensuring compliance and accuracy across various labeling documents.
About Regeneron
Regeneron is a leading biotechnology company dedicated to discovering, developing, and delivering life-changing medicines for serious diseases. With a strong commitment to scientific excellence and innovation, Regeneron operates globally, focusing on improving patient outcomes through advanced therapeutic solutions. The company fosters a collaborative work environment that values diversity and inclusion.
Job Details:
- Company: Regeneron
- Location: Hyderabad, India (Hybrid)
Regeneron Regulatory Affairs Job Description
In this role, the Regulatory Affairs Labeling Specialist will support global regulatory labeling activities, ensuring compliance, accuracy, and operational excellence across labeling documents, submissions, workflows, and reporting processes. The specialist will collaborate closely with Regulatory Labeling Leads, operations teams, and cross-functional stakeholders to maintain high-quality product labeling and support global regulatory compliance.
Key Responsibilities
- Support Regulatory Labeling Leads in managing labeling compliance activities and tracking deviations from Company Core Data Sheets (CCDS).
- Maintain safety variation trackers, labeling compliance trackers, and other regulatory documentation.
- Contribute labeling inputs for annual reports and periodic safety reports (PBRER/PADER) for assigned products.
- Conduct competitor labeling analysis using digital tools, including AI-enabled applications.
- Perform quality control reviews for EU linguistic reviews and localization activities for SmPCs and Package Leaflets.
- Format, hyperlink, proofread, and quality check CCDS, USPI, and SmPC documents according to regulatory standards and checklists.
- Perform text comparison, annotation reviews, and cumulative redline preparation for labeling updates.
- Create and coordinate Structured Product Labeling (SPL) development, validation, and regulatory submissions.
- Support packaging update activities and associated Veeva workflows.
- Manage labeling workflows within Veeva and support system updates, testing, and process improvements.
- Develop and maintain detailed labeling timelines in Planisware and monitor key deliverables.
- Compile labeling metrics, analyze trends, and identify opportunities for automation and process enhancements.
- Coordinate Labeling Working Group meetings and maintain critical labeling governance documentation.
Eligibility Criteria
- Bachelor’s degree in Life Sciences, Pharmacy, Health Sciences, or a related scientific field.
- 2+ years of experience in the biotechnology or pharmaceutical industry, preferably in Regulatory Labeling or Regulatory Affairs.
- Knowledge of global regulatory requirements and health authorities, including FDA, EMA, and international labeling regulations.
- Strong expertise in Microsoft Word and proficiency with Microsoft Office applications.
- Experience working with Veeva Vault and regulatory document management systems preferred.
- Familiarity with Structured Product Labeling (SPL), labeling quality control, and submission processes.
- Experience utilizing AI and digital tools for labeling management is highly desirable.
- Excellent attention to detail, organizational skills, and ability to manage multiple priorities simultaneously.
- Strong analytical, communication, and stakeholder management skills.
- Ability to work independently and collaborate effectively within a global matrix organization.
- Regulatory Labeling Operations experience.
- Knowledge of SmPC, USPI, CCDS, QRD requirements, and labeling compliance processes.
- Experience supporting global product labeling and lifecycle management activities.
- Exposure to automation and digital transformation initiatives within Regulatory Affairs.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Regeneron offers a unique opportunity for qualified candidates to contribute to impactful regulatory labeling efforts in the biotechnology field. Candidates interested in this Regeneron Regulatory Affairs Job are encouraged to apply promptly to seize this opportunity.
