Regulatory Affairs CMC

Job Description:

• Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various commercial and/or development product applications.

• Support regulatory activities for the strategies aligned with Health Authority requirements from a global perspective, and supporting the on-time submission of regulatory submissions.

• Additional duties may include regulatory compliance administrative support

• Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites.

• Provide support for other CMC projects and tasks as needed.

Basic Qualification:

- Bachelor's degree with 2 years experience in a Regulatory Affairs related role

- Fluency in the understanding and format of the Common Technical Document (CTD)

- Authoring experience of CTD Module 2 & Module 3 sections

- Excellent writing skills

Basic understanding of pharmaceutical manufacturing processes

Best Regards,

Anuj Mehta

973-967-3402