Senior Manager Regulatory Submission Operations

Job description

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 Senior Manager, Regulatory Submission Operations — IRAS/MHRA to join our Regulatory Submission Operations team in Hyderabad. In this role, you will lead the in-house IRAS/MHRA submission function, managing a team of Regulatory Submission Operations Specialists and overseeing the end-to-end delivery of Clinical Trial Authorisation (CTA) submissions via the IRAS portal — including quality oversight, RFI management, and cross-functional stakeholder coordination. You will also contribute hands-on to submission activities and, over time, may oversee broader regulatory publishing work, including the formatting and building of electronic submission deliverables in accordance with applicable regulatory agency requirements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: Hyderabad, India (hybrid) Discover your role: • Directly manage a team of Regulatory Submission Operations Specialists, providing day-to-day direction, workload allocation, and performance oversight. • Review and quality-check IRAS portal submissions, RFI responses, and related outputs prepared by the team prior to submission or issue. • Support the onboarding, training, and ongoing development of team members, building in-house IRAS expertise within the RegOps function. • Act as an escalation point for complex submission issues, RFI queries, or stakeholder conflicts, ensuring timely resolution. • Communicate resource needs, capacity constraints, and team performance to senior management as required. • Foster a culture of quality, accountability, and continuous improvement within the team. • Depending on organizational need, provide administrative and line management oversight for other functions within Global Development — such as Regulatory CMC and/or Labelling & Ad Promo — with people management accountability while technical and scientific accountability remains with the relevant functional leads. • Oversee and contribute to the completion and submission of CTA applications and amendments via the IRAS portal, drawing on programme-level knowledge and Clinical Study Team (CST)-sourced information. • Ensure robust 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 ensure effective quality control review and information gathering ahead of submissions. • Oversee end-to-end RFI management, including tracking, response quality, timelines, and alignment with internal team members; call out issues as appropriate. • Maintain and develop submission tracking frameworks, ensuring accurate records and proactive identification of risks across the portfolio. • Serve as the senior in-house point of contact for IRAS portal queries, troubleshooting issues and liaising with MHRA as required. • Provide guidance to multidisciplinary teams on MHRA submission strategies in accordance with applicable regulatory requirements and internal standards. • Manage staff who electronically format, publish, and build regulatory submission deliverables (e.g., INDs, CTAs, BLAs, MAAs and their amendments/supplements), ensuring quality, accuracy, and submission-readiness per regulatory agency guidance and internal procedures. • Perform review and validation of submission documents to ensure compliance with FDA, ICH, and other applicable guidelines, including submissions through eCTD format. • Provide guidance on good documentation and submission practices across the team and to wider programme participants. • Lead or contribute to the development and maintenance of regulatory document processing and submission publishing standards and SOPs. • Identify regulatory system enhancement needs or technical issues and work closely with systems and technical support teams to develop and implement solutions. • Assist with regulatory inspection activities as required. • Collaborate with vendors who support regulatory operations-related tasks, maintaining oversight of deliverable quality and timelines. This role requires: • Bachelor's Degree in Life Sciences, Pharmacy, or a related field. • 8+ years of experience in a regulatory operations, regulatory affairs, or clinical submissions environment. • Demonstrated experience managing or leading a team in a regulatory or operations context. • Hands-on experience with the IRAS portal and MHRA CTA submissions strongly preferred. • Proven track record of managing RFI processes and regulatory submission lifecycles. • Knowledge of applicable regulatory agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, MHRA). • Experience working in or alongside a CRO or transitioning work in-house is advantageous. • Proficiency with the IRAS portal (or demonstrable ability to r