We are looking for Regulatory Associate - CMC for our client in Indianapolis, IN
Job Title: Regulatory Associate - CMC
Job Location: Indianapolis, IN
Job Type: Contract
“W2 candidates are encouraged to apply. We are unable to sponsor H1b or work with third-party candidates at this time.”
- 3+ years experience in a CMC/Chemistry Manufacturing and Controls position OR 3+ years Module 3 experience (a regulatory app that is specific to CMC).
- Also Microsoft Office experience.
- Soft skills in Project Management and Project planning, sewing projects from beginning to end, working within the group, to ensure they are staying on task and able to meet deadlines, etc.
- Pharma experience specifically.
- Device experience would be helpful.
- Combination of product experience, device regulatory experience.
- Good knowledge of regulatory requirements, specifically the US, EU, and Japan.
- 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 client 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, guidance, and regulatory precedence.
- The Regulatory Associate will triage and manage the communications between our client 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.
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