Associate-Global Regulatory Affairs-Regulatory Delivery & Excellence-Regional Regulatory Associate

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The purpose of the Regional Regulatory 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 Asia Pacific region and contribute local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indications

Monitor, 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.

1. Provide Regulatory, Submission Planning and Execution Expertise of all submission types

Manage planning and tracking submission-level data in RIM for the affiliate and ensure RIM data is correct for Right-to-Operate submissions. Inform the affiliate and/or external business alliance partner of planned/upcoming submissions.

Prepare local Module 1 documents in RIM per appropriate regional submission and route for appropriate review and approval in collaboration with Lilly Affiliate Regulatory and/or Alliance Managers/Associates

Manage submission package compilation and non-eCTD publishing work in RIM submission content plans.

Coordinate with affiliate and regional regulatory leaders to align on “next-best submission date” in case of inability to meet Accelerate Reach and Scale goal. Escalate issues that may impact submissions and timelines and support their resolution.

If applicable, support local activities to enable submission (e.g. fee payment, MoH appointment etc)

Conduct 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 Regulatory 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.

Ensure compliance and audit-readiness data in RIM.

2. 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 priorities

Collaborate 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.

Collaborate with GRA-CMC and Lilly Affiliate Regulatory and/or Alliance Managers/Associates to complete impact assessment for upcoming post approval changes.

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.

Manage submission package compilation and non-eCTD publishing work in RIM submission content plans.

3. 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.

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 experience

Knowledge 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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