Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Indianapolis, IN

Duration: 18+ Months

Description

Qualifications:

MUST REFLECT ON RESUME: 3+ years experience in a CMC/Chemistry Manufacturing and Controls position OR 3+ years Module 3 experience (regulatory app that is specific to CMC). Also Microsoft Office experience. Other requirements include: Soft skills of Project Mgmt 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 exp specifically. Device experience would be helpful. Combination products experience, device regulatory experience. A good knowledge of regulatory requirements, specifically US, EU, and Japan.

Responsibilities:

The GRA-CMC Regulatory Associate leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global clinical trial and marketing authorization submission management processes. The Regulatory Associate also partners with GRA-CMC Scientists to help create and manage submission content and 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/Regulatory Representatives. The Regulatory Associate utilizes GRA-CMC submission process expertise and their expertise with information technology tools to develop project management expectations across projects. 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 submission specialists and project management for clinical trials and marketed product support.