Cmc Regulatory Technical Writer - Remote

W2 Contract Role Through October 2023

Description:

• Assist with ongoing GXP systems transition, related to change control and regulatory dossiers.
• Ad hoc RA CMC support to line manager.
• Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
• Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders.
• Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation.

Qualifications:

• Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company
• Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance
• Detail oriented and highly organized
• Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents
• Works well in team setting on a fast-paced business critical project
• Excellent project management skills
• Good writing skills for technical writing
• Scientific and educational background (Bsc or MSc) to understand pharmaceutical drug development concepts, regulatory concepts and create documentation based on these concepts

***EEO***

***Compensation is based on experience***