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Regulatory Affairs Manager

2019-10-15 19:23:50 in Others » 0 590
Position: Regulatory Affairs Manager (100K-130K but flexible) 
Ref: O003/2019
Client: An international pharmaceutical company
Location: Downtown Bangkok near BTS/MRT
Date: 24 Aug 2019
 

Fantastic opportunity to work for a global pharmaceutical company with a convenient work location!

Our client is one of leading and global pharmaceutical companies with a convenient work location in downtown Bangkok.  The Company seeks an experienced Regulatory Affairs Manager to join its team for continual business growth.  

Responsibilities:

  • Present dossiers for registration of pharmaceutical products and discussed scientific issues with relevant authorities for timely drug registration
  • Provide regulatory support of marketed products
  • Assure conformity of dossiers to the local statutory requirements
  • Provide inputs to the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs
  • Submit dossiers for local products, like renewals of MAA or Variations, such as labelling changes, line extensions, advertisement, pharmaceutical changes, etc.
  • Prepare the dossiers for price/reimbursement of the products with the Marketing and Medical Affairs interfaces
  • Maintain permanent relationship and frequent contacts with the Health Authorities and forge good relationships with local FDA authorities and relevant government bodies
  • Deal with regulatory bodies both in Thailand and HQ, including registration authorities to get products registered
  • Communicate with Regional and Global to get the right dossiers, prepare and submit registrations dossiers according to updated requirements
  • Validate the pharmaceutical dossiers on the "old" products
  • Manage quality problems (i.e. complaints, batch recalls, etc.)
  • Update the registration database i.e. maintain records of all registration activities, artworks labeling and promotional material approval
  • Provide report of new regulations and business impact
  • Keep abreast of Industry Association for new regulations
  • Ensure the company comply to related act e.g. pharmacovigilance
Qualifications :-
  • Thai nationality only
  • Bachelor's degree in Pharmacy and a higher education is an advantage  
  • 10 years of experience in drug registration, preferably from leading/MNC pharmaceutical companies 
  • Good knowledge of drug registration requirements
  • Willingness to travel extensively
  • Good contacts with Regulatory Authorities i.e. Thai FDA
  • Strong persuasive skill plus good communication and interpersonal skills
  • Pleasant personality, details-oriented, with the ability to deal with top level of regulatory authorities
  • Computer Literacy (Microsoft Word, Power Point, Excel, Outlook)
  • Good command of English is a must
     
    All applications will be treated strictly confidential. Only short-listed will be notified.
    Interested candidates please submit your resume stating your current and expected salary to:

     
    Career Connection Recruitment Co., Ltd.
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    M: 095 469 0990