Regulatory Affairs Labeling Specialist Role at Regeneron | Apply Now
A rare opportunity has emerged for aspiring professionals seeking a Regeneron regulatory affairs job in Hyderabad, India, as the company is seeking a Regulatory Affairs Labeling Specialist. This role offers an opportunity to support global regulatory labeling activities while ensuring compliance and operational excellence. Interested candidates are encouraged to apply soon.
About the Company
Regeneron is a leading biotechnology company dedicated to discovering, developing, and delivering life-changing medicines for people with serious diseases. With a strong commitment to scientific excellence and innovation, Regeneron operates globally and focuses on improving patient outcomes through its advanced therapeutic solutions.
Job Details
- Location: Hyderabad, Telangāna, India (Hybrid)
- Job Reference Number: R49592
Regeneron Regulatory Affairs Job Description
In this Regeneron regulatory affairs job, 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.
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.
Documents Required
- Resume/CV
- Cover letter
- Relevant educational qualifications
How to Apply
Interested candidates can apply for the position by visiting the official Regeneron careers page at
Additional Information
Regeneron is committed to building a workplace with an inclusive culture. The company is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, or any other characteristic protected under applicable law.
Regeneron offers a competitive and comprehensive total rewards package, which may include annual bonuses, equity awards, health and wellness programs, and more. For further details about Regeneron benefits, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
Conclusion
This Regeneron regulatory affairs job is an excellent opportunity for qualified candidates to join the company as a Regulatory Affairs Labeling Specialist in Hyderabad. Interested individuals are encouraged to apply before the deadline to take the next step in their career.
