HEAD of Regulatory Affairs
HEAD of Regulatory Affairs
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Job Description
Head of Regulatory Affairs (RA) will drive strategic planning and execution for regulatory operations in Thailand ensuring alignment with business objectives. This role involves liaising with FDA officials overseeing review and submission of registrations responding to deficiencies and providing crucial regulatory guidance to internal teams. Responsibilities also include providing post-approval changes safety labelling and annual updates to the FDA within the required timelines and format. Ensuring timely filing and approvals of all regulatory documentation is essential for maintaining operational efficiency.
Roles & Responsibilities
Regulatory Strategy & Compliance
- Develop and implement regulatory strategies to ensure compliance with Thai FDA and international standards.
- Monitor regulatory changes and provide strategic guidance to internal teams.
- Ensure timely submission and approval of product registrations variations and renewals.
Government & Stakeholder Engagement
- Act as the primary liaison with Thai FDA Ministry of Public Health and other regulatory bodies.
- Represent the company in industry forums and regulatory discussions.
- Advocate for favourable regulatory policies and industry best practices.
Product Registration & Lifecycle Management
- Oversee the preparation and submission of regulatory dossiers for new and existing products.
- Ensure compliance with GMP GCP and GLP standards.
- Manage post-approval regulatory activities including labelling updates and safety reporting.
Cross-functional Collaboration
- Work closely with R&D Quality Assurance Legal and Commercial teams to align regulatory strategies with business objectives.
- Provide regulatory insights for product development and market expansion.
Risk Management & Compliance Oversight
- Identify regulatory risks and develop mitigation strategies.
- Ensure adherence to local and global regulatory requirements.
- Conduct internal audits and training sessions on regulatory compliance.
Qualifications :
Qualifications Experience Skills & Attributes
Educational qualification: A Bachelor or Master degree in Pharmacy
Minimum work experience: 15 years experience in Thai pharmaceutical industry
Skills & attributes:
- Strong knowledge of Thai FDA regulations ASEAN regulatory frameworks and international compliance standards
- Proven leadership experience in managing regulatory teams and government relations.
- Excellent communication (English and Thai) and negotiation skills.
- Expertise in drug registration clinical trial approvals and pharmacovigilance.
- Established network and experience with regulatory authorities.
- Ability to navigate complex regulatory environments and influence policy decisions
- Strong analytical and problem-solving skills
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
