Regulatory Affairs Manager - Johor Bahru, Malaysia - Tiger Balm (Malaysia) Sdn Bhd
Description
Responsibilities:
1.
New product registration:
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.
- 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.
- Update and maintain database of regulatory and product registration information.
- Good maintenance of final submitted documentation and local repository.
- Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.
- Support any audits or inspections.
- Guide/ oversee work performance and development of direct report.
- Provide input for periodic operation metrics/ budget initiatives by managing operating expenses within approved budget for the year.
- 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.
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