Work as Senior Manager Regulatory Submission Operations at Regeneron

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® (RGC) and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

Post : Senior Manager Regulatory Submission Operations

Job Description
• 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.

Candidate Profile
• 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 rapidly gain proficiency).
• Advanced knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems.
• Familiarity with document publishing tools, eCTD validation and viewing tools, and XML is desirable.
• Experience with submission tracking tools or regulatory information management systems.
• Strong people management skills with the ability to motivate, develop, and hold a team accountable.
• Excellent stakeholder management and communication skills, including the ability to work cross-functionally and across regions.
• High attention to detail with a quality-first attitude.
• Ability to manage multiple priorities and call out risks proactively in a fast-paced environment

Additional Information
Experience : 8+ years
Qualification : Bachelor's Degree in Life Sciences, Pharmacy
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Development
End Date : 31st August 2026