Regulatory Submission Operations Specialist

Build our future together: Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases.

In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

We are seeking a Regulatory Submission Operations, Specialist — IRAS/MHRA to join our Regulatory Submission Operations team in a hybrid role. In this role, you will be responsible for the end-to-end management of MHRA Clinical Trial Authorization (CTA) submissions via the IRAS portal — including portal form completion, document management, and RFI alert triaging — while working closely with Regulatory Affairs Liaisons and programme teams to ensure accurate, timely, and compliant submissions.

Over time, the role may expand to include broader regulatory submission operations activities, such as formatting and building of electronic submission deliverables in accordance with applicable regulatory agency requirements. Ensure compliance with Regeneron SOPs, regulatory requirements, and industry best practices.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: Hyderabad (hybrid) Discover your role: Complete and submit CTA applications and amendments via the IRAS portal, drawing on programme-level knowledge and Clinical Study Team (CST)-sourced information.

Manage document upload, version control, and organisation within the IRAS portal in alignment with MHRA requirements and internal submission timelines. Coordinate with Regulatory Affairs Liaisons to support quality control review and information gathering ahead of submissions.

Support coordination of RFIs (Requests for Information) by tracking open queries, following up on responses, and liaising with relevant teams to ensure timely and accurate inputs. Maintain accurate submission tracking records and proactively escalate risks or issues to programme teams as appropriate.

Serve as the in-house point of contact for IRAS portal queries, troubleshooting portal issues and liaising with MHRA as required. Electronically format, publish, and build regulatory submission deliverables (e.g., INDs, CTAs, BLAs, MAAs and their amendments/supplements) in accordance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, ICH).

Ensure quality, accuracy, and submission-readiness of documents per regulatory agency guidance and internal procedures. Provide guidance on good documentation and submission practices. Assist with developing and maintaining regulatory document processing and submission publishing standards and procedures.

Assist with regulatory inspection activities as required. Collaborate with vendors who support regulatory submission document-related tasks. This role requires: 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 environment.

Hands-on experience with the IRAS portal and MHRA CTA submissions strongly preferred. Familiarity with RFI management processes and regulatory submission lifecycles. Knowledge of applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, ICH, MHRA).

Experience working in or alongside a CRO or in-house RegOps function is advantageous. Ability to work with firm deadlines and adapt quickly to changing priorities. Proficiency with the IRAS portal (or demonstrable ability to rapidly gain proficiency).

Strong knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems. Familiarity with document publishing tools, eCTD validation, and viewing tools. Experience with submission tracking tools or regulatory information management systems is an advantage, including Veeva Vault.

Good interpersonal, oral, and written communication skills. 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.