Regulatory CMC Specialist

1 semana atrás


Brasil beBeeregulatory Tempo inteiro R$80.000 - R$120.000
Regulatory CMC Specialist

As a key member of our team, you will be responsible for providing regulatory support for assigned projects. This includes collaborating with Global RA CMC lead and/or Regional RA CMC led to develop submission plans and contribute to the execution of timely and innovative regulatory strategies.

Key Responsibilities:
  • Develop and execute submission plans to ensure timely and compliant regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA).
  • Collaborate with cross-functional teams to define CMC content requirements for regulatory submissions.
  • Prepare and coordinate the review and approval of submission-ready documents, ensuring completeness and accuracy.
  • Review submission documents to ensure clear and consistent messaging, and perform final copyediting checks.
  • Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data.


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