About this role

  • Posted on

  • Location

    United States Virgin Island

  • Salary

    Up to €0.00 per hour

  • Type

    Contract

  • Division

    Pharmaceutical Regulatory Affairs Jobs

  • Reference

    BBBH24505_1646912228

  • Start date

    ASAP

  • Managing this role

Consultant

Ella Cooper

07891025734

154-158 Shoreditch High Street

Description

Are you looking for an exciting new oppertunity to advance your skills, lead a team and gain expierence?

I have a contract role open at the moment that could be perfect for you.

I am looking for CMC professionals with the following expierence

* Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
* Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers
* Experience in reviewing of quality documents such as Reformulation studies, process validations, particle size method implementation and specification, stability indicating methods implementation, impurity < 1% qualification, repeating stability studies, in use stability studies, assay methods (anti-oxidant assay, anti-microbial agent assay), sterile filter testing, preservative effectiveness testing.
* Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal.

Please get in touch with me at for a confidential chat or apply below

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