Global Regulatory Affairs Specialist

hace 3 días


San José, San José, Costa Rica Lilly A tiempo completo

Job Summary:

The Regional Submission Coordinator plays a critical role in supporting affiliate regulatory and business alliance partnerships in emerging markets within the International Region, with a focus on Latin America.

This position requires strong technical expertise in Veeva Vault RIM system and experience with global regulatory business processes.

Key Responsibilities:

  • Serve as Subject Matter Expert (SME) for global regulatory business processes and Veeva Vault RIM system execution.
  • Support affiliate regulatory and alliance partnerships with Veeva Vault RIM submission management.
  • Monitor, manage, and execute country post-approval submission plans by providing a submission-ready dossier and performing related system updates and maintenance.

RIM Content Planning:

  • Support Affiliate Regulatory/Alliance Managers with RIM content planning for all submission types.
  • Match appropriate documents to the RIM content plan, send content plan for review, and lock and confirm the top-level content plan when complete.
  • Send notification for export to Affiliate Regulatory/Alliance Managers and/or eCTD publisher.

Post-Approval Submission Coordination:

  • Manage the post-approval submission agenda for all products in assigned countries/regions, monitoring post-approval submission plans and workload to achieve planned submission dates.
  • Collaborate with Lilly Affiliate Regulatory and Alliance Managers/Associates and directly interact with external alliance business partners and liaise with cross-functional partners to achieve optimal post-approval submission plans, ensuring compliant product availability.
  • Create RAPT/RIM Renewal and Manufacturing Site Registration/Renewal records and maintain planned/target/actual submission and approval dates for all post-approval activities in collaboration with the Affiliate/Alliance Manager.

Affiliate Regulatory RIM System Support:

  • Ensure affiliate regulatory teams are appropriately supported with RIM system training and technical assistance.

Requirements:

  • Strong technical expertise in Veeva Vault RIM system.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Able to work effectively in a fast-paced environment.

What We Offer:

  • Competitive compensation and benefits package.
  • Ongoing professional development opportunities.
  • Diverse and inclusive work environment.


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