Apply Today! Regulatory Affairs Job at Regeneron | Pharma Graduates Eligible
Looking for a Regulatory Affairs Job with a leading global biopharmaceutical company? Regeneron Careers has announced an exciting opportunity for a Regulatory Submission Operations Specialist (IRAS/MHRA) in Hyderabad, Telangana. This position is ideal for Life Sciences and Pharmacy graduates with up to two years of experience in regulatory operations or clinical submissions. If you’re eager to build your career in global regulatory affairs, this Regulatory Affairs Job through Regeneron Careers offers the chance to work on international regulatory submissions while contributing to life-changing medicines.
- Job Title: Regulatory Submission Operations Specialist
- Location: Hyderabad, Telangāna, India
- Department: Global Development
- Job ID: R49074
About The Company
Regeneron is a leading global biotechnology company committed to inventing, developing, and commercializing life-changing medicines for serious diseases. Through innovation and cutting-edge science, the company continues to transform healthcare while providing rewarding career opportunities for professionals worldwide.
Job Description
Regeneron is hiring a Regulatory Submission Operations Specialist (IRAS/MHRA) to join its Regulatory Submission Operations team. The selected candidate will manage end-to-end MHRA Clinical Trial Authorization (CTA) submissions through the IRAS portal, including portal completion, document management, version control, and Requests for Information (RFI) coordination.
Key Responsibilities
- Complete and submit CTA applications and amendments through the IRAS portal.
- Manage document uploads, organization, and version control.
- Coordinate with Regulatory Affairs Liaisons for submission quality reviews.
- Support Requests for Information (RFI) tracking and follow-up.
- Maintain submission tracking records.
- Troubleshoot IRAS portal issues and communicate with MHRA.
- Format and publish electronic regulatory submissions including INDs, CTAs, BLAs, and MAAs.
- Ensure documents meet FDA, EMA, ICH, and MHRA requirements.
- Maintain regulatory publishing standards.
- Assist during regulatory inspections.
- Collaborate with external regulatory submission vendors.
Qualifications
- Bachelor’s Degree in Life Sciences, Pharmacy, or a related discipline.
- Up to 2 years of experience in Regulatory Operations, Regulatory Affairs, or Clinical Submissions.
- Experience with the IRAS portal and MHRA CTA submissions is preferred.
- Knowledge of FDA, EMA, MHRA, and ICH regulations.
- Familiarity with RFI management and regulatory submission lifecycles.
- Proficiency in Microsoft Word, Adobe Acrobat, and Electronic Document Management Systems.
- Experience with Veeva Vault, eCTD publishing, and validation tools is advantageous.
- Strong communication and organizational skills.
Required Skills
- Regulatory Affairs
- Regulatory Submission Operations
- IRAS Portal
- MHRA CTA
- eCTD Publishing
- Regulatory Documentation
- Clinical Trial Authorization
- FDA Regulations
- EMA Guidelines
- ICH Guidelines
- Veeva Vault
- Adobe Acrobat
- Microsoft Word
- Submission Tracking
- Document Management
Why Join this Role?
- Opportunity to work with a globally recognized biotechnology company.
- Exposure to international regulatory submission processes.
- Hybrid work model in Hyderabad.
- Career growth in Regulatory Affairs and Regulatory Operations.
- Work on innovative medicines that improve patients’ lives.
- Collaborative, science-driven, and employee-focused work environment.
