Regulatory Affairs Jobs at Regeneron
A unique opportunity has arisen at Regeneron for a Regulatory Affairs Labelling Specialist in Hyderabad, India. This Regulatory Affairs Job invites qualified candidates to contribute to global regulatory labelling activities while ensuring compliance and operational excellence in a dynamic environment.
About Regeneron
Regeneron is a leading biotechnology company that focuses on discovering, developing, and delivering life-changing medicines for serious diseases. With a commitment to scientific excellence and innovation, Regeneron operates globally, striving to improve patient outcomes through its advanced therapeutic solutions.
- Job Details:
- Location: Hyderabad, Telangāna, India (Hybrid)
- Reference Number: R49592
Job Description
In this Regulatory Affairs Job as a Regulatory Affairs Labelling Specialist, the selected candidate will support global regulatory labelling activities, ensuring compliance, accuracy, and operational excellence across labelling documents, submissions, workflows, and reporting processes. Collaboration with Regulatory Labelling Leads and cross-functional stakeholders will be essential to maintain high-quality product labelling and support global regulatory compliance.
Key Responsibilities
- Support Regulatory Labelling Leads in managing labelling compliance activities and tracking deviations from Company Core Data Sheets (CCDS).
- Maintain safety variation trackers, labelling compliance trackers, and other regulatory documentation.
- Contribute labelling inputs for annual reports and periodic safety reports (PBRER/PADER) for assigned products.
- Conduct competitor labelling analysis using digital tools, including AI-enabled applications.
- Perform quality control reviews for EU linguistic reviews and localisation 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 labelling updates.
- Create and coordinate Structured Product Labelling (SPL) development, validation, and regulatory submissions.
- Support packaging update activities and associated Veeva workflows.
- Manage labelling workflows within Veeva and support system updates, testing, and process improvements.
- Develop and maintain detailed labelling timelines in Planisware and monitor key deliverables.
- Compile labelling metrics, analyse trends, and identify opportunities for automation and process enhancements.
- Coordinate Labelling Working Group meetings and maintain critical labelling 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 Labelling (SPL), labelling quality control, and submission processes.
- Experience utilising AI and digital tools for labelling management is highly desirable.
- Excellent attention to detail, organisational 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 organisation.
- Regulatory Labelling Operations experience.
- Knowledge of SmPC, USPI, CCDS, QRD requirements, and labelling compliance processes.
- Experience supporting global product labelling and lifecycle management activities.
- Exposure to automation and digital transformation initiatives within Regulatory Affairs.
This Regulatory Affairs Job is an excellent opportunity for qualified candidates to join Regeneron as a Regulatory Affairs Labeling Specialist in Hyderabad. Interested applicants are encouraged to apply before the deadline to be part of a team dedicated to transforming lives through innovative therapies.
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