Essential Job Duties And Responsibilities

• Compliance Management: The Regulatory Affairs Head is responsible for staying abreast of all applicable regulations and ensuring that the company's policies and practices align with these requirements.
• Regulatory Strategy: Developing and implementing regulatory strategies that support the overall business objectives of the company. This includes planning for product registrations, approvals, and compliance activities.
• Communication with Regulatory Agencies: Serving as the main point of contact between the company and regulatory agencies. This involves submitting applications, responding to queries, and facilitating inspections or audits.
• Product Registration and Life-Cycle Maintenance: Overseeing the preparation and submission of regulatory documents and applications required for product approval or market authorization.
• Policy Development: Developing and maintaining internal regulatory policies and procedures to ensure that the company's practices align with regulatory requirements.
• Cross-functional Collaboration: Collaborating with other departments such as research and development, quality assurance, marketing, and legal to ensure that regulatory considerations are integrated into all aspects of the business.
• Risk Management: Identifying and assessing regulatory risks and developing strategies to mitigate them.
• Training and Education: Providing training to employees on regulatory requirements and changes to ensure a company-wide understanding of compliance obligations.
• Advisory Role: Providing strategic regulatory advice to senior management and other stakeholders to inform decision-making processes.
• Monitoring Industry Trends: Keeping abreast of changes in the regulatory environment, Industry standards, and best practices to ensure the company's ongoing compliance and competitiveness.
• Others: Perform related duties as assigned by supervisor.

Qualifications: Minimum Qualification

Education:

• A bachelor's degree in pharmacy or a related discipline is typically the minimum requirement.
• Understanding of the technical and scientific aspects of the industry

Experience:

• Substantial experience minimum 15 years or more in regulatory affairs within the pharmaceuticals
• Progressive experience in roles of increasing responsibility, including leadership or management positions in regulatory affairs.

Regulatory Knowledge:

• In-depth knowledge of Thailand, LCM and international regulatory requirements and standards relevant to the pharmaceuticals
• Experience dealing with ThFDA and a proven track record of successful interactions.

Leadership and Management Skills:

• Strong leadership skills with the ability to lead and manage a team of regulatory professionals.
• Demonstrated ability to develop and implement regulatory strategies that align with business goals.

Communication Skills:

• Excellent communication skills, both written and verbal, to effectively interact with internal teams, regulatory agencies, and other stakeholders.
• The ability to convey complex regulatory information in a clear and understandable manner

Problem-Solving and Decision-Making:

• Strong analytical and problem-solving skills to navigate complex regulatory issues.
• The ability to make informed and timely decisions in accordance with regulatory requirements.

Project Management:

• Proficient project management skills to coordinate and execute regulatory activities within specified timelines. Experience overseeing multiple projects simultaneously.

Strategic Thinking:

• Strategic thinking and the ability to align regulatory activities with the overall business strategy.

Attention to Detail:

• Strong attention to detail, crucial for ensuring accuracy and completeness in regulatory submissions.

Continuous Learning:

• A commitment to staying updated on changes in regulatory requirements and industry trends.

Other requirements

• Pharmacist License in Thailand