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.