Regulatory Affairs Manager(Thailand)
3 weeks ago
**仕事内容**:
**Title: Regulatory Affairs Manager - Thailand**
**Location**:Empire Tower, Tower2, 25th floor.Room 2511
**Key Responsibilities**:
- Develop and implement regulatory strategies and plans for product developmentand submissions.
- Lead interactions with regulatory agencies.
- Ensure compliance with regulatoryrequirements throughout the product lifecycle
- Provide guidance on regulatory issues to project teams and senior management.
- Review and approve technical documentation, including clinical trial protocolsreports,and marketing materials.
- Monitor changes in regulatory environment and adjust strategies accordingly
- Manage and mentor a team of regulatory professionals.
- Participate in due diligence for potential business partnerships or acquisitions
**Qualifcations**:
- Bachelor's degree in a relevant scientific field; advanced degree preferred.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge ofTFDA and other related international regulatory guidelines
- More than 5 years of experience in pharmaceutical-related regulatory affairsincluding involvement in registration projects for new drugs or biologics.
- Possession of a pharmacist license.
- Familiarity with drug registration processes in non-PiC/s countries
- Excellent communication and interpersonal skills.
**その他**:
Pay: ฿80,000.00 - ฿90,000.00 per month
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