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Senior Regulatory Submissions Manager

Senior Regulatory Submissions Manager

G&L ScientificHyderabad, Telangana, India
21 hours ago
Job description

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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    Senior Manager • Hyderabad, Telangana, India

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