Regeneron
Website:
regeneron.com
Job details:
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? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.
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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
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.
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