Senior Regulatory Submissions Manager

4 weeks ago


India G&L Scientific Full time

Senior Regulatory Submissions Manager Please only apply if you are an immediate joiner Location: Hybrid working from our office locations in Mumbai/Navi Mumbai/Hyderabad We are seeking two Senior Regulatory Submissions Managers to play a pivotal role in shaping how regulatory submissions are managed within our new Veeva RIMS platform. This is a high-impact opportunity to influence process design, system configuration, and regulatory compliance across a global organization. Duties will include: Define Submission Management Processes - Lead the design and documentation of end-to-end Regulatory Submission Management workflows - Partner across RA, QA, Clinical, and IT to identify process gaps and drive operational excellence Translate Business Needs into Veeva Configuration - Convert business requirements into Veeva RIMS configuration specifications - Collaborate with IT and Veeva consultants to ensure the system supports planning, tracking, publishing, and archival of submissions Ensure Compliance & Best Practice Alignment - Align processes with Health Authority expectations and industry standards - Maintain robust documentation of decisions, processes, and configurations Serve as SME & Project Contributor - Act as Subject Matter Expert in workshops, design sessions, testing cycles, and UAT - Help guide change management and end-user adoption Person Specification: - Experienced in Regulatory Affairs and Submissions Management - Hands-on familiarity with Veeva RIMS (or comparable regulatory systems) - Strong communicator, collaborator, and process-thinker - Comfortable influencing cross-functional teams in a global environment Why join G&L? This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants. If you're passionate about regulatory excellence and digital transformation in life sciences, we'd love to hear from you.



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