Regulatory Associate

CMC Regulatory Specialist

Qualifications:

Demonstrated knowledge of post-approval Chemistry, Manufacturing and Control (CMC), including submission planning and tracking

Proficiency in assessment of global CMC requirements

Knowledge and understanding of ICH requirements regarding CTD formatting

Proficiency in eCTD systems and format

Strong computer skills with proficiency in Microsoft Office applications

Proficiency in Sharepoint

Proven ability to take initiative and identify opportunities to contribute to product and process improvements

Self-motivated individual with demonstrated ability to identify issues and solutions for a positive result

Demonstrated analytical thinking and problem solving skills

Proven strong written and verbal communication skills

Demonstrated capability to track numerous communications and ensure timely response and completion of deliverable

Flexibility and ability to handle time pressures

Ability to prioritize workload and organize accordingly

Effective interpersonal skills; can work as part of a team

HS Diploma or equivalent required

General required skills also include multi-tasking numerous parallel projects, positive attitude and willingness to explore new solutions

Responsibilities:

The CMC (Chemistry, Manufacturing, and Controls) Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. This includes supporting the registrations of Lilly products sourced from the US and/or contributing manufacturing sites, for both Lilly and contract manufacturing sites, to the global marketing affiliates. In this role, the Specialist works closely with Indianapolis regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. The Specialist works closely with Indianapolis regulatory product representatives providing essential CMC commitment information and approval status in global markets as part of manufacturing change control evaluation/completion. The Specialist appropriately updates impacted regulatory documents as part of the change control process. Key customers include the Regulatory representatives, Indianapolis manufacturing sites and the CMC Regional Centers. The Regulatory Specialist is expected to provide leadership and business process knowledge to these customers along with organization skills and prioritization ability to identify, initiate and maintain global product CMC commitments for Lilly marketed products.