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Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

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Associate Director, Regulatory Affairs

  • Location:

    California

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Yuan Xie

  • Salary:

    US$150000 - US$180000 per annum + Bonus and Benefits

  • Job type:

    Permanent - full time

  • Contact email:

    Yuan.Xie@msipharma.com

  • Job ref:

    VR/04256_1669194933

  • Published:

    15 days ago

  • Startdate:

    01/01/2023

MSI Pharma is currently hiring a Regulatory Affairs Associate Director for one of our Pharma clients in the US.

The Associate Director Regulatory Affairs will be responsible for the regulatory review and approval of all labeling, based on development and management of a target product profile (TPP);

Oversee and coordinate the regulatory review and approval of all commercial materials through the Promotional Review Committee (PRC) and interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.

Principal Responsibilities:


* Review and approve product labeling (including all advertising and promotional materials) and participation in design reviews to ensure adherence to regulatory requirements as set forth in the CFRs.


* Develop, implement, and maintain procedures in support of regulatory compliance.


* Develop and manage TPPs for products, working with cross-functional disciplines.


* Assist with the development and implementation of regulatory labeling strategies for existing, new and modified products.


* Provide review and approval of product and process changes, as required, to ensure compliance with regulatory requirements.


* Assist in developing and documenting sound regulatory decisions and justifications and advising organization on impact of changing regulations.


* Interpret product, policy and process changes to ensure compliance with regulatory requirements.

If you would like to know more information or apply please feel free to reach out.

Looking forward to connecting!