Senior Regulatory Submissions Manager

ConfidentialHyderabad / Secunderabad, Telangana, India

1 day ago

Job description

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.

Skills Required

Regulatory Affairs

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Senior Manager • Hyderabad / Secunderabad, Telangana, India