This position is to responsible for Regulatory Affairs manager of Pharmaceutical.

Responsibility :-

1.Regulatory Strategy Development

• Develop and implement regulatory strategies aligned with business goals and current trends.
• Identify regulatory requirements and potential challenges early in product development.

2.Submission Management

• Prepare, review, and submit regulatory documentation to Thai FDA for product registration and variations.
• Manage submission timelines and deliverables to ensure timely approvals.

3.Compliance Oversight

• Ensure products meet local, national, and international regulations throughout their lifecycle.
• Monitor and communicate changes in regulatory requirements to relevant teams.

4.Regulatory Agency Interactions

• Act as the primary contact for regulatory agencies, ensuring clear communication and effective problem-solving.
• Lead presentations during agency meetings to address inquiries and progress submissions.

Qualifications :-

• University Degree in Pharmaceutical Science. Master Degree will be a plus.
• Proven track record in handling product registration with Thai FDA
• Minimum 3-5 years experience in managing product registration processes in Pharmaceutical in a multinational environment.
• At least 3 years experience in Pharmaceutical Registration field is a plus
• Have a strong connection with Thai FDA is a plus
• Good understanding of regulatory compliance and strong knowledge of local regulatory requirements for product registration.
• Strong planning, organizing and analytical skills.
• Outstanding problem solving and decision making skills.
• A professional attitude and high ethical standards.
• Good networking skills and result-oriented.
• Excellent communication skills in both Thai and English (verbal and written).
• Good computer skills.