Senior Regulatory Submissions Manager

1 day ago

Navi Mumbai, Maharashtra, India G&L Scientific Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Contract: Permanent Full-Time

Closing Date: 05/12/25

We are seeking 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.

The Role

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
Requirements

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.

How to Apply

If you would be interested in joining the team at G&L Scientific, please send your CV to [email protected] today.

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.

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