Associate, Regulatory Biosimilars Group

Job Description

-Responsible for regulatory activities specifically related to chemistry, manufacturing,
and control (CMC). Activities such as the preparation and publication of REG CMC
documentation for submissions to Health Authorities. In addition interact with HA's on REG
CMC questions to support new product or post marketed launches.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

-Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting
agreed upon timelines and e-publishing requirements.
-Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
-As needed, coordinate /collect /store source documentation needed for direct submission to Health Authorities.
-Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
-Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
-Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt 1/
-Distribution of marketing samples (where applicable)
Additional Specifications