Reg Associate Manager II - LM CD CMC Renewals

Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and / or maintenance of business activities

Prepare sections of registration files, briefing books, clinical trials applications, chemistry, manufacturing and controls variations, renewals files, and responses to Regulatory Agency questions,

Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities

Ensure close partnership with authors, assuring technical congruency and regulatory compliance

Apply system and procedure updates to maintain proper records and support adequate controls

Provide evaluations for potential changes as requested and follow up to ensure regulatory compliance and completion of appropriate internal compliance records

Effectively communicate regulatory requirements and guidelines, facilitating timely and complete submissions

Develop up-to-date knowledge to guidelines and regulatory requirements, as well as technical trends