|Job Title:||CMC Consultant|
|Contact Name:||Alastair McCartney|
|Job Published:||July 10, 2017 14:21|
Project work will range from administrative (formatting per client guidelines, obtaining information in client systems) to complex (developing regulatory strategies for global rollout of post-approval CMC changes and authoring associated submissions) and is dependent upon the needs of the client.
- Preparation of Marketing Authorisation Applications, Clinical Trial Authorisation applications and INDs
- Preparation of requests for Scientific Advice from FDA, EMA and EU National Authorities
- Support for customers in Regulatory Authority meetings; advice on regulatory strategy; due diligence on existing data packages
- Advice on individual study designs, taking into account product type and therapeutic class, and review and interpretation of study data
- Clinical trial legal representative services for non-EU companies and US Agent services for non-US companies
- Participates in product development team meetings to ensure inclusion of CMC requirements across various stages of the drug development/approval process. Provides guidance to client on issues impacting CMC information.
- Develops regulatory strategies for post-approval CMC changes by utilizing existing regulatory affairs knowledge and client systems/ processes.
- Continues to develop familiarity with regulations and regulatory guidelines and strategy for various biological.
- Develops working knowledge of regulatory standards, practices, corporate policies, practices and departmental SOPs/work practices · Provides guidance to other peers concerning biologics rules and regulations.
- Provides guidance to other peers concerning client systems and processes.
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