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CMC Compliance Lead

CMC Compliance Lead

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CMC Compliance Lead

  • Location:

    United States of America

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Yuan Xie

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    Yuan.Xie@msipharma.com

  • Job ref:

    VR/04107_1655396437

  • Published:

    17 days ago

  • Duration:

    12 months

  • Startdate:

    ASAP

We are hiring a experienced CMC Compliance Expert to work on a fully remote basis within the US!

Key Functions include:

* Experienced in authoring of assessment reports


* Reviewing of quality documents (e.g. reformulation studies, process validations, particle size method implementation and specification etc)


* Serve as the CMC Product Lead for assigned products


* Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes


* Manage execution / authoring of CMC documentation

Ideal candidate would have:

* Marketing authorization experience


* Project Management experience


* 8-12 years of experienced in Pharmaceutical Regulatory Industry/ CMC


(Please note that candidate's quality will be reviewed on an overall basis)

Looking forward to hearing from you soon!