Country Regulatory Affairs Specialist - Thailand- for 6 months Contract
Location:
Klongtoey District, Bangkok, Thailand
Role Summary:
The role involves preparing and compiling product dossiers for Health Authority submissions, ensuring timely receipt and approval of documents. It requires collaboration with stakeholders to manage change control assessments and maintain compliance with SOPs. Responsibilities include tracking submissions, updating regulatory databases, and handling artwork-related activities. Additionally, the role involves responding to Health Authority queries and supporting post-marketing requests. The Specialist combines scientific and regulatory knowledge to ensure products comply with local legislation and company procedures, collaborates with cross-functional teams to enhance regulatory initiatives and drive compliance, and leverages expertise in regional regulations, health authority expectations, and industry trends to support regulatory compliance.
This is a hybrid role with a requirement of office visits 2-3 times per week, and to visit the local Health Authorities as required.
Primary Responsibilities of Regulatory Affairs Specialist
Regulatory Submissions & Dossier Management
- Preparation and compilation of assigned product dossiers for HA submission, including preparation of Module 1 local documents (Application form, cover letter, commitment letter, sample commitment, and updates in QRD file if required).
- Assist in submission of dossiers and supportive documents to Health Authorities on time; track and follow up on submissions with HAs for status and approval.
- Promptly respond to queries and interact with Health Authorities to ensure smooth filing and approval processes.
- Update and maintain submission trackers, keeping the regulatory guidance database current based on the latest local regulatory information and updated guidelines.
- Update and archive submissions and documents, maintaining the database with current submission and approval dates.
Qualified Person & License Holder Responsibilities
- Bear full responsibility and accountability for the filing of regulatory applications and the authenticity of all documents submitted to the FDA.
- Ensure that all documentary and technical requirements and information provided in applications, together with all submissions, amendments, and supplementary data, are true and correct based on existing records, legal documents, and other validated sources.
- Oversee product safety, quality, and regulatory documentation to ensure compliance with applicable regulatory standards and product release requirements.
- Ensure compliance of the establishment with FDA procedural guidelines, including adherence to prescribed format and content of administrative and technical documentary requirements, timely communications and coordination with the FDA pertaining to regulatory filings, post-market surveillance, pre-licensing inspections, and routine inspections.
- Identify and apply for variations (major, minor, or by notification, as applicable) for any changes in the establishment's status or previously authorized activities, submitting all corresponding documentary and technical requirements to ensure continuous compliance with FDA requirements and standards.
- Ensure compliance with all applicable regulatory training requirements for health products and health product establishments, for both the Qualified Person and associated establishment personnel.
- Maintain valid qualifications and credential requirements at all times
Stakeholder Collaboration & Change Control
- Collaborate and maintain proactive communication with different stakeholders to ensure timely receipt of supporting documents, submissions, approvals, and implementation.
- Proactively identify procedural gaps and challenges, and implement solutions in collaboration with all affected stakeholders.
- Conduct change control assessments and provide filing strategy with necessary guidance to various stakeholders.
Compliance & SOPs
- Act in full compliance with global and local SOPs; report any deviations or compliance concerns immediately and assist in preparing necessary CAPAs for non-compliance issues.
- As delegated, ensure awareness of obligations to comply with regulatory requirements and applicable statutory requirements throughout the establishment and supply chain.
Artwork & Post-Marketing Support
- Involved in artwork-related activities including initiation of artwork requests/mock-ups, tracking, review, and approval of country-specific artworks.
- Support agency requests by providing post-marketing samples, declarations, and certificates.
Qualifications
Skills (professional and/or technical):
- Excellent communication and time management skills, the ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently across markets.
- Ability to effectively negotiate and influence management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.
- Fluency in Thai and English (written and spoken) languages is a must.
Work Experience
- 4-5 years of relevant experience in working with local Health Authorities.
Education/Certificates
- The candidate must have a health, life science, or medical science degree or equivalent by education.
- The candidate must be a locally registered pharmacist.
