February 24, 2009

  • This weekend I went to Mont Tremblant to ski, hotpot and hang out at a cabin with my friends (finally a younger bunch!).  I wonder when I can be a competent skiier / snowboarder.... I need to practise some more this weekend!

    Random questions: If I live in a trendy loft one day, where am I going to put my bike, snowboard, skis, clothes, shoes, cat litter box, books, toiletries, photo frames, 6x4ft world map?  If I am to take a year sabatical, should I ask if I can learn a year of french in france, or find a job in my field in USA... or just veg / tutor / learn and daytrade / do biz in Asia...? 

    We'll see what will happen.  Two weeks ago my friend said that she will be the last to get married b/c she doesn't have a bf, today she told me her new serious bf wants to get married at 28 if possible!  Tout est possible! 

    The economy is so bad.  I got to be glad that I am riding the recession well b/c eventhough my mutual funds are not doing well, I have a gov't job, and my neighbourhood actually appreciated!  I personally think that it is a great opportunity to invest, both short-term and long-term, if you know what you are doing!

    Live the life you want to live~

February 11, 2009

October 27, 2008

  • You learn

    Got this from a friend's fb...

    After a while you learn the subtle difference Between holding a hand and chaining a soul, And you learn that love doesn't mean leaning And company doesn't mean security. And you begin to learn that kisses aren't contracts And presents aren't promises, And you begin to accept your defeats With your head up and your eyes open With the grace of a woman, not the grief of a child, And you learn to build all your roads on today Because tomorrow's ground is too uncertain for plans And futures have a way of falling down in mid-flight. After a while you learn... That even sunshine burns if you get too much. So you plant your garden and decorate your own soul, Instead of waiting for someone to bring you flowers. And you learn that you really can endure... That you really are strong And you really do have worth... And you learn and learn... With every good-bye you learn...

October 8, 2008

  • Dec13-Jan2 ----> Hong Kong trip approved!  I can't wait to be in HK and Singapore!

    Other than that, bummed...

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

     

September 16, 2008

September 11, 2008

  • 080815: Sorry, deserted Xanga b/c i was busy with travelling, working on the house, and facebooking instead.

    080911: I'm learning Spanish~  Fun!  I know I should be focusing on French but it is good to have variety!  I have an awesome business idea which is half charity today.  Bill Gates calls it Creative Capitalism.  Already half way through the business case.  It is going to be FUN~  House, market is stable in Ottawa.  Want to look into a few places in the states but I guess if I want to do the business idea, I need to change focus for now.  Jobs, most talked with recruiters but hard b/c I am not leaving town for interviews.

     

August 21, 2008

  • Five years Xangan as of June 8, 2008!

    I have vision when I got the lifetime premium membership.    You got to say it is impressive to have stayed with one provider for over 5 years!

    I don't know if anyone has read my Xanga since the beginning, but thank you for participating in part of my life.

     

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.

August 15, 2008

  • Chinese (HKer) Canadian, appreciates good friends, enjoys pissing off mean people, easy going, sentimental, very adventurous but cautious, likes real estate since 7, inquisitive, can be confused, needs advise, gives advise, independent but needs attention, likes to learn, mostly sensitive, shy by nature, extroverted by choice, mostly warm but can be cold, idealistic but practical, very adaptive, liberal and open-minded but enjoys some conservatism, not a shopaholic, mostly not vain, diver, loves photos, blogger, loves languages, electric biker, hates winter, loves summer, phone queen, planner, organizer, doesn't like to live alone, cat owner, housekeeper, pleaser, full-time public servant, part-time traveller (just like the rest of my family), part-time sociologist.