Prepare and compile registration dossiers in accordance with relevant regulatory requirements including:
Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.Conduct checks on artworks to ensure in compliance with local regulation.
Submit product registration applications to local health authorities according to target submission timelines.
Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.
2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.
Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
Propose solutions to arising issues.
4. Update and maintain database of regulatory and product registration information.5. Good maintenance of final submitted documentation and local repository.6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.7. Support any audits or inspections.8. Guide/ oversee work performance and development of direct report.9. Provide input for periodic operation metrics/ budget initiatives by managing operating expenses within approved budget for the year.10. Handle any other assingment as advised by supervisor.Requirements:
Possess a Bachelor Science
Work experience in regulatory affairs.
Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
Proficiency in Microsoft Office Applications and relevant regulatory system software.
Adopt good practices in documentation and communication.