Regional Submission Coordinator

hace 6 días

San José, Costa Rica Lilly A tiempo completo

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview and Purpose:
The Regional Submission Coordinator (RSC) will be part of a regional team, providing core support to affiliate regulatory and business alliance partnerships the emerging markets within the International Region, while the specific position will focus on the Latin-America.
- Serve as the Subject Matter Expert (SME) for global regulatory business processes and how those are executed in the Veeva Vault RIM system to ensure consistency of process execution and data.
- Support affiliate regulatory and alliance partnerships with Veeva Vault RIM submission management.
- Monitor, manage and execute the country post approval submission plan (i.e., CMC variations, product license renewals) by providing a submission ready dossier to affiliate regulatory or external alliance partner and performing related system updates & maintenance.

**Responsibilities**:
**Build high level of technical expertise (RIM) and support process improvement initiatives**
- Achieve a high level of technical and practical proficiency with Veeva Vault RIM.
- Stay up to date on system upgrades.
- Make recommendations to the RIM Change Control Board on potential system configuration changes, and support business process or training improvements based on user feedback.
- Support the evaluation of new opportunities for centralizing/regionalizing tasks.
- Actively participate in supporting cross-functional activities/projects regarding submissions.

**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 when review complete, lock & confirm the top-level content plan.
- 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. Additional submission activities (e.g. Manufacturing Site Registrations) may be assigned.
- 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. When creating Renewal and Manufacturing Site Registration/Renewal records, obtain confirmation from Affiliate/Alliance Managers.
- Periodically inform the external business alliance partner of planned/upcoming submissions.
- Complete or support completion of ACRR form.
- Clarify requirements by liaising with various support groups for efficient submission activities.
- Track support status and ensure on time availability by early support planning and follow up with support providers.
- For products for which Lilly holds the license, evaluate received documentation or obtain evaluation outcome from business alliance partner & follow-up on amendments to meet requirements.
- For products for which Lilly holds the license, prepare/draft module 1 documents in alignment with affiliate regulatory.
- Match appropriate documents to the RIM content plan, send content plan for review and when review complete, lock & confirm the top-level content plan.
- Send notification for export to Affiliate Regulatory and/or eCTD publisher. For products for which the external business alliance partner holds the license, export the content plan, send to the partner for submission, and confirm with the partner the requirement to submit the complete package.
- For products for which an external alliance business partner holds the license, perform archiving activities (e.g. submitted dossier, incoming Health Authority correspondence) as described in the contract.
- Record and archive incoming Health Authority questions & send to response owner.
- Support technical compilation of responses.
- Escalate issues that may impact submissions and timelines and support their resolution.

**Affiliate regulatory RIM system support**:

- Ensure affiliate regulatory are appropriately

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