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Regulatory Affairs Senior Manager (100-150K)

2015-12-28 10:49:52 in Others » 0 651
Position: Regulatory Affairs Senior Manager (100-150K)
Ref: O001/2015
Client: International pharmaceutical company
Location: Sathorn
Date: 14 Dec 2015

Responsibilities:
  • Lead regulatory strategy to be in line with company goals and strategy.
  • Work with regional regulatory team and/or business partners to develop regulatory strategies and update it based upon regulatory changes.
  • Assess emerging issues and develop solutions to address those with other members of management, stakeholders and business partners.
  • Manage the preparation and submission of regulatory dossiers/documents throughout product life cycle including advertisement permits.
  • Manage regulatory aspects of business relationships including with the health authorities to ensure regulatory compliance and protect company interests.
  • Manage the review of promotional materials and packaging materials to be in compliance with FDA requirements.
  • Oversee the management of regulatory compliance activities e.g. packaging material control for redressing, product release, product complaint handling, etc.
  • Ensure regulatory function to be in compliance with corporate & regional policies, procedures and practice as well as local regulations.
  • Oversee the management of pharmacovigilance and quality system activities at local level and ensure that these activities are performed according to corporate & regional procedures and/or business partner’s pharmacovigilance SOP/agreement.

Qualifications:
  • Thai Nationality
  • Bachelor’s Degree or higher in Pharmacy or related field
  • Have strong regulatory expertise in pharmaceutical with at least 5 years of regulatory experience in managerial position. Familiarity with medical device, cosmetic and other consumer health product regulation will be advantageous.
  • Good command of English and computer literacy
 
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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