Regulatory Affairs Manager
3 months ago
Job Description:
**Location**: Pathumwan, Bangkok
**Type of Hiring**: Permanent
**Responsibilities**:
- Independently manage routine regulatory activities for the assigned product portfolio.
- Oversee the registration of new products and line extensions according to the planned schedule to ensure timely product launches.
- Handle the renewal of product licenses, company licences, GMP clearances, and any amendments as needed.
- Keep registration licences current throughout the products lifecycle in compliance with local regulations and emerging data, where applicable.
- Ensure that all changes and quality issues related to regulatory activities are effectively managed according to internal procedures.
- Provide regulatory input and recommendations to ensure adherence to current applicable regulatory laws and regulations.
- Assist in reviewing labelling and promotional materials to ensure they meet regulatory requirements.
- Develop and maintain strong working relationships with local health authorities and other relevant regulatory agencies.
- Contribute to regulatory associations' working groups and other regulatory projects as required, under the supervision of the manager.
- Perform additional duties as assigned by the superior from time to time.
**Qualifications**:
- Bachelors degree in Pharmaceutical Sciences
- Minimum of 5 years experience in Regulatory Affairs, specifically concerning pharmaceutical products
- Strong command of English, particularly in writing skills
- Highly responsible, well-organised, and capable of working effectively as part of a team with a positive attitude and open-minded approach
- Excellent collaboration and communication skills with all relevant stakeholders
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