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Description
Head of Regulatory Affairs, Thailand and LCM (Innovative Medicine)
Essential Job Duties And Responsibilities
The role of a Regulatory Affairs Head is a critical and strategic position within an organization. The primary responsibility of a Regulatory Affairs Head is to ensure that the company complies with all relevant laws and regulations pertaining to its products or services for Thailand, Laos, Cambodia, and Myanmar (LCM). Overall, the Regulatory Affairs Head plays a crucial role in navigating the complex regulatory landscape, ensuring that the company's products or services meet the necessary standards, and mitigating regulatory risks. The position requires a combination of legal, scientific, and business acumen to effectively navigate regulatory challenges and contribute to the overall success of the organization.
- 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
