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 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.

The purpose of the Regional Submission Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E) role is accountable for the operational and technical local and/or regional registration management processes that support the expedited delivery of safe and effective products to patients.

Manage country-specific submission requirements for assigned geographic area and contribute local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indicationsMonitor, manage and execute 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.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 submission management.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Provide Regulatory, Submission Planning and Execution Expertise

Create local Module 1 documents in RIM and manage reviews/approvals with affiliate staffPrepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review and approvalFor eCTD countries: Collaborate with Global Regulatory associate to match local Module 1 documents to the Global content planFor non-eCTD countries: Match appropriate documents to the local RIM content plan, send content plan for review and when review complete, lock & confirm the top-level content plan.Coordinate with affiliate and regional regulatory leaders to align on “next-best submission date” in case of inability to meet Accelerate Reach and Scale goalEnsure local activities to enable submission are completed (e.g. fee payment, MoH appointment etc)Manage planning and tracking submission-level data in RIM for the affiliate and ensure RIM data is correct for Right-to-Operate submissionsConduct impact assessment of local regulation changes and manage submission requirements and templates for assigned countries in central systems (e.g. R-Cubed/RIM templates)Collaborate within Regional Submission Associate team to identify opportunities for harmonisation of requirements, challenge affiliate on dossier requirements when they stand in the way for harmonisation/globalisation and work closely with regional regulatory policy team to identify and influence areas of improvements in the external environment.

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.Coordinate with GRA-CMC and Supply chain to ensure post-approval changes are submitted in accordance with global manufacturing prioritiesCollaborate with Lilly Affiliate Regulatory and/or 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 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 ManagersCollaborate with GRA-CMC to conduct impact assessment for upcoming post approval changes and complete the relevant assessment (e.g. ACRR form).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.

Support affiliate and alliance submission management

Periodically inform the affiliate and/or external business alliance partner of planned/upcoming submissions.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 trained on the RIM system and associated business processes for regulatory submissions and registration management.Provide hands on training as necessary for affiliate RIM tasks

Personal and Professional Development

Build and maintain knowledge and understanding of local and if appropriate regional regulations and submission requirements for countries of responsibility and other submission elements, as needed.Create and maintain a positive and effective working environment and, if applicable, effectively lead, manage, and motivate direct reports and support them in extending their technical skills. Assure appropriate recognition.Manage own performance and development by actively setting and meeting individual professional development goals.

Minimum Qualification Requirements:

Bachelor’s degree or higher in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experienceKnowledge of drug development process Demonstrated ability to implement strategies and plans to improve complex processes.

Other Information/Additional Preferences:

Proven ability to develop and deliver both strategic and tactical plans.A deep understanding of quality systems and process management.Proven ability to influence cross functionally without direct authority.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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