Life Science Jobs at Regeneron | Apply Now
Are you looking for Life Science Jobs in a leading global biopharmaceutical company? Regeneron Careers has announced an exciting opportunity for the position of Regulatory Submission Operations Specialist in Hyderabad. If you have a background in Life Sciences or Pharmacy and are interested in Regulatory Affairs Jobs, this role offers the chance to work on global regulatory submissions, clinical trial applications, and compliance activities while contributing to the development of life-changing medicines.
About Regeneron
Regeneron is a global biotechnology company founded on the belief that the right ideas and the right people can transform healthcare. The company focuses on inventing, developing, and commercialising innovative medicines for serious diseases through cutting-edge science, advanced manufacturing, and breakthrough research. With a strong commitment to improving patient lives worldwide, Regeneron continues to be a leader in scientific innovation and global healthcare.
Key Responsibilities
- Complete and submit Clinical Trial Authorisation (CTA) applications and amendments through the IRAS portal using programme-level knowledge and Clinical Study Team information.
- Manage document uploads, version control, and organisation within the IRAS portal in accordance with MHRA requirements and submission timelines.
- Coordinate with Regulatory Affairs Liaisons to support quality control reviews and information gathering before submissions.
- Support Requests for Information (RFI) coordination by tracking queries, following up on responses, and collaborating with relevant teams.
- Maintain accurate submission tracking records and escalate risks or issues when necessary.
- Serve as the primary contact for IRAS portal-related queries and coordinate with MHRA for issue resolution.
- Electronically format, publish, and build regulatory submission deliverables, including INDs, CTAs, BLAs, and MAAs, following FDA, EMA, ICH, and MHRA guidelines.
- Ensure submission documents are accurate, compliant, and ready for regulatory agency review.
- Provide guidance on documentation and regulatory submission best practices.
- Assist in developing regulatory document processing and submission publishing standards.
- Support regulatory inspection activities.
- Collaborate with external vendors involved in regulatory submission document-related activities.
Qualifications
- Bachelor’s Degree in Life Sciences, Pharmacy, or a related discipline.
Experience
- Up to 2 years of experience in regulatory operations, regulatory affairs, or a clinical submissions environment.
- Hands-on experience with the IRAS portal and MHRA CTA submissions is strongly preferred.
- Experience working in or alongside a CRO or an in-house Regulatory Operations function is advantageous.
- Experience with submission tracking tools or Regulatory Information Management Systems, including Veeva Vault, is an advantage.
Skills Needed
- Knowledge of IRAS portal and MHRA CTA submission processes.
- Familiarity with RFI management and regulatory submission lifecycles.
- Knowledge of FDA, EMA, ICH, and MHRA regulations, guidelines, and specifications.
- Ability to work under firm deadlines and adapt to changing priorities.
- Strong proficiency in Microsoft Word, Adobe Acrobat, and electronic document management systems.
- Familiarity with document publishing tools, eCTD validation, and viewing tools.
- Strong interpersonal, verbal, and written communication skills.
- Ability to ensure regulatory compliance and maintain high-quality documentation.
If you’re searching for Life Science Jobs, Regeneron Careers, or Regulatory Affairs Jobs, this Regulatory Submission Operations Specialist position in Hyderabad is an excellent opportunity to build your career in global regulatory operations while contributing to the development of life-changing medicines. Apply today and take the next step with Regeneron Careers.
