Regulatory Affairs Manager

2 weeks ago


Johor Bahru, Johor, Malaysia Tiger Balm (Malaysia) Sdn Bhd Full time

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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