Regulatory Technical Writer – REMOTE

Proclinical is seeking a Regulatory Technical Writer for a leading pharmaceutical company. This is a contract role with the opportunity to work remotely.

Must be eligible to work in the US.

Job Responsibilities

• Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market– specific requirements and leading information request response preparation
• Track submission activities and change controls for RACMC and ensure visibility to cross– functional CMC stakeholders
• Assist with ongoing GXP systems transition, related to change control and regulatory dossiers
• Ad hoc RA CMC support to line manager

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at (+1) 267– 297– 3257 or j.jones@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.