CMC Writer
Brazil, Remote Additional Locations: Argentina, Remote;Mexico, Remote 求人ID R0000030831 Category Regulatory / ConsultingAbout this Role
We are looking for a CMC Writer to join our Regulatory Affairs team. Interested candidates should have experience in CMC (small molecules, biologics) - change control assessments, submission planning for variations and renewals and management, coordination and execution for variations and responses to Health Authority questions.
Expertise required:
- Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects.
- Collaborate with Global RA CMC lead and/or Regional RA CMC led to provide regulatory support for assigned projects
- Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post-approval supplements and variations.
- Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA).
- Prepare and coordinate the review and approval of submission-ready documents.
- Ensure submissions are complete and accurate and comply with applicable regulatory requirements and expectations.
- Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copyediting check.
- Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data.
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