Regulatory Affairs Specialist (3-5)

Regulatory Affairs Specialist (3-5)

Location: Remote/Indianapolis, IN

Duration: 19 Months

Qualifications:

3+ years of experience in a CMC/Chemistry Manufacturing and Controls position (regulatory document experience) OR 3+ years Module 3 experience (regulatory application specific to CMC). Also Microsoft Office experience.

Other requirements include: Soft skills of Project Management and Project Planning, seeing project from beginning to end, working with in the group, to ensure they are staying on task and able to meet deadlines, etc. Preferences - Nice to haves include: Pharma experience specifically. Device experience would be helpful. Combination products experience, device regulatory experience. A good knowledge of regulatory requirements, specifically with knowledge of changes in the US or EU.

Responsibilities:

The GRA-CMC Regulatory Associate leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Regulatory Associate also partners with GRA-CMC Scientists to help create and manage submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidances and regulatory precedence. The Regulatory Associate will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, Specialists, and the Quality/Reg Representatives. The Regulatory Associate utilizes GRA-CMC submission process expertise and their expertise with Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, the GRA-CMC Regulatory Associate will be responsible for routine communication of submission tracking requirements to both GRA-CMC Scientists and internal customers. The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.