September 20, 2008

  • What is the odds of landing some expat job like this in a few years...
    *drool*  need to get industry experience... need.... to be an inspector... need to talk to recruitment agencies....

    BioPharma CMC Regulatory Manager, South Korea


    This is a once in a lifetime US Expat opportunity to work abroad in business friendly South Korea contributing to the development of a new world class BioPharmaceutical Company.

    Working and living in South Korea is realistic and an extraordinary opportunity for US Expatriates: 

    * Advance your career by setting the standards a new world class BioPharmaceutical Company
    * Take advantage of financial benefits including company paid housing, automobile & driver, fantastic international schooling for children, airfares to visit the US, and a full medical, dental & disability insurance package.   
    * Incredible tax breaks will allow you larger take home income than working in the States.
    * Generous 5 week vacation time allowing you trips to the US and opportunities to explore Asia.
    * Interact with leaders within the global biotechnology and pharmaceutical industry. 
    * South Korea is a politically stable, safe and a friendly country for American’s to live and work.  The Korean economy is rapidly growing and is heavily developing their biotechnology industry. 


     

    BioPharma CMC Regulatory Manager, South Korea

    You will be responsible for leading BioPharma CMC Regulatory activities for the successful development of clinical, commercial, and post marketed biologic drug products.  You will be responsible for performing the following activities:

    * Development and execution of CMC regulatory strategies involving post approval changes for biologic drug products.
    * Project Management by interfacing and meeting with Manufacturing, Regulatory, and Quality departments to foster understanding of product development processes and changes.
    * Driving and executing regulatory submissions including BLA filings, IND filings, annual reports, renewals, supplemental applications, and maintenance dossiers.
    * Contributing to CMC sections on new and existing IND and BLA filings.
    * Interfacing directly with the FDA, EMEA, Health Canada, and other global regulatory agencies. 

    Preferred Candidate Background and Expertise:

    * Over 5 years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry Regulatory Affairs experience with expertise working on developing Biologics, Biopharma, monoclonal antibody, or recombinant protein products.
    * BS degree required.
    * Regulatory Affairs experience working on a post approved/commercial/marketed biologic product.
    * Experience interacting directly with global regulatory agencies including the FDA, EMEA, and Health Canada.
    * Strong experience contributing to CMC sections on new and existing IND and BLA filings.


    *** PLEASE NOTE – THIS POSITION IS LOCATED IN SOUTH KOREA – PLEASE APPLY ONLY IF YOU ARE OPEN TO RELOCATING ABROAD TO WORK IN SOUTH KOREA ***

    Expatriate Benefits Package:

    * Company paid housing in South Korea.
    * Tax Breaks on US Federal and Korean taxes.
    * 5 weeks of vacation time.
    * International school paid for children.
    * Full medical, dental & disability insurance benefits.
    * Company cell phone.
    * Food service at company cafeteria.
    * Company paid airfares to visit the US (or country of origin).

    For immediate confidential consideration, please email your resume directly to Jeff Schwartzman - jeff@lagunasource.com

     

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