August 17, 2008

  • I want to figure out how my experience in the gov't can be bridged into the private section in either the US, HK, England, Swiss etc. further ahead.

    I have exp in drug Reg affairs, quality (ISO Quality mgmt systems), AND clinical trials, but not in industry setting.  Which of the three shall I focus on?  My mandarin and french would ACTUALLY be useful in a swiss company in HK.  How nice if I can work there?

    They asked me for an interview for a clinical job, but I think they expected me to be in HK already.  No response from them afterwards.  Please please give me sth fulfilling in the future.  I'll just roll with the punches and see where I'll land.

     

    PositionTitle                           Director

    QualityOperations&RegulatoryAffairsAsiaPacific

     

    Company/Legal EntityChina Chiron Limited Hong Kong
    Functional AreaRegulatory Affairs
    Job TypeFull Time
    Employment TypePermanent
    Job DescriptionThe position is in charge of ensuring that the organization is in compliance with all AP countries regulatory requirements as well as Novartis Quality System requirements.
    Main accountabilities:
    . Monitor pending regulatory legislation for AP countries and transposition of international Directives into local legislation
    . Support products registration directly or through agents or distributors for new countries
    . Implement and monitor the Quality Management System for AP region
    . Work with US Quality Head to implement and monitor the Novartis Quality Management System
    . Act as Business Continuity Management Leader for Business continuity plan
    . Work with US Regulatory Head to prepare and monitor filings as required supporting business development objectives.
    . Meet with regional regulatory authorities to negotiate requirements needed to secure approval.
    . Review industry regulatory trends, stakeholder initiatives and competitor actions to develop strategies to support the commercial, scientific and regulatory objectives within the region.
    . Establish strong relations with key regulatory opinion leaders and industry groups to support Novartis Vaccines and Diagnostics’s position within the region.
    . To be the Regulatory key contact and spokesperson for regulatory matters within Asia Pacific.
    . Develop and negotiate regulatory approval processes including regulatory test-ing strategies and regulatory trial design to meet commercial needs and time-lines of the company.
    . To work with commercial team to evaluate the cost, timing and benefits asso-ciated with new product registration or development of business cases for new country entry.
    . Appoint, negotiate contracts and manage third party regulatory agencies or regulatory personnel within our distributors as required.
    Minimum requirementsEducation:Degree in Life Science
    Languages:English (Mandarin also but not essential)
    Experience/Professional requirement:
    •10 years quality experience in a commercial environment in a multinational company.
    •1-5 years experience with regulatory filing preparation.
    •In depth knowledge of FDA, ex-USA and ISO regulation requirements as well as standard Quality management tools and standards.
    •Strong experience in cGMP requirements.