CMC Writer
Brazil, Remote Additional Locations Buenos Aires,Argentina;Mexico Destrito Federal,Mexico Job ID R0000030831 Category Consulting Date Posted 01/27/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About 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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