Senior Regulatory Submissions Manager

Key Responsibilities:

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

Required Skills & Experience:

• Experience 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 Us?

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.