2015-12-28 10:49:52 in Others » 
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| 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. |
| APPLY |
M: +66 95 469 0990
T: +662 207 2654 |
Telephone: +66-64 654 9955 | 
Email: contact@careerconnection-th.com
