Regulatory Affairs Labeling Specialist

Regeneron Pharmaceuticals, Inc; Hyderabad; Hybrid; INR 900,000 - 1,200,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Regulatory Affairs Labeling Specialist to join its Hyderabad team.

You will support global labeling activities, ensuring regulatory compliance, accuracy, and operational excellence across labeling documents, submissions, and workflows. The role requires collaboration with labeling leads, operations, and cross-functional partners to maintain high-quality product labeling.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Health Sciences, or related field.
• 2+ years in biotech/pharma, preferably Regulatory Labeling or Regulatory Affairs.
• Knowledge of FDA, EMA, and international labeling regulations.
• Proficiency with MS Word and MS Office applications.
• Experience with Veeva Vault or regulatory document systems preferred.
• Knowledge of SPL, SmPC/USPI/CCDS, labeling QC and submission processes.
• Experience with AI/digital tools for labeling management is desirable.
• Strong attention to detail, organization, and multitasking.
• Analytical, communication, and stakeholder management skills.
• Ability to work independently and in a global matrix organization.
• Regulatory Labeling Operations experience.
• Exposure to labeling lifecycle management and QRD requirements.
• Automation and digital transformation in Regulatory Affairs experience.

Responsibilities

• Support Regulatory Labeling Leads in managing labeling compliance and CCDS deviations.
• Maintain labeling trackers and regulatory documentation.
• Contribute labeling inputs for annual and safety reports (PBRER/PADER).
• Conduct competitor labeling analysis using digital tools, including AI-enabled apps.
• Quality control for EU linguistic reviews and localization of SmPCs and Leaflets.
• Format and quality check CCDS, USPI, and SmPC documents per standards.
• Prepare redlines and annotations for labeling updates.
• Coordinate SPL development, validation, and regulatory submissions.
• Support packaging updates and Veeva workflows.
• Manage labeling workflows in Veeva; support system updates and testing.
• Develop and maintain labeling timelines in Planisware; monitor deliverables.
• Compile labeling metrics, identify automation opportunities, and drive process improvements.
• Coordinate Labeling Working Group meetings and governance documents.

Skills

Regulatory labeling

Documentation management

Stakeholder management

Attention to detail

Regulatory compliance

Education

Bachelor’s degree in Life Sciences/Pharmacy/Health Sciences

Tools

Veeva Vault

Microsoft Word

Regulatory document management systems

Job description

Build Our Future Together

At Regeneron, we believe that the right idea, combined with the right team, can transform lives. Our global teams are dedicated to discovering, developing, and delivering life-changing medicines for people with serious diseases. We are committed to scientific excellence, innovation, and improving patient outcomes worldwide.

We are seeking a Regulatory Affairs Labeling Specialist to join our Regulatory Affairs team in Hyderabad. In this role, you will support global regulatory labeling activities, ensuring compliance, accuracy, and operational excellence across labeling documents, submissions, workflows, and reporting processes. You will collaborate closely with Regulatory Labeling Leads, operations teams, and cross‑functional stakeholders to maintain high-quality product labeling and support global regulatory compliance.

When & Where

Location: Hyderabad, India (Hybrid)

Discover Your Role

• 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.

This Role Requires

• 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 labelsing and lifecycle management activities.
• Exposure to automation and digital transformation initiatives within Regulatory Affairs.

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.