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Regulatory Affairs Manager
 2019-10-15 19:23:50 in Others »  0  772
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 :-
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Thai nationality only
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Bachelor's degree in Pharmacy and a higher education is an advantage
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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)
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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. |
| APPLY |
| M: 095 469 0990 |
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Telephone: +66-64 654 9955 | 
Email: contact@careerconnection-th.com
