Muthia Rachma

Experience

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  PT Kalbe Farma

  Mar 2012 - Dec 2013

  Regulatory Affairs

  ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.

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  PT Bintang Toedjoe

  Jan 2014 - Apr 2025

   Ensuring and managing the appropriate licensing, marketing and legal compliance of pharmaceutical and consumer health products in order to control the safety and efficacy of products. Update the Regulation (Include Regulatory Impact Assessment) and combining the knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, comply and meet the required legislation. Providing strategic advice to senior management and stakeholders throughout the development of a new product. Advise on and coordinate the approval and registration of consumer health product in drug/pharmaceuticals, food , food supplement and Traditional Medicine category. Handling regulatory compliance project of Bintang Toedjoe consumer health brand (monitoring and setting timelines for licence new product, variations and renewal approvals) include advertisement approval from BPOM. Handling Product Halal Certification of all Bintang Toedjoe Product. Show less Overview :Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.Combine the knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, meet the required legislation.We advise on and coordinate the approval and registration of pharmaceuticals, food , food supplement and other products.Work activities :- ensuring that a company's products comply with the regulations of the NADFC and Ministry of Health;- Collecting, collating and evaluating scientific data that has been researched by colleagues;developing and writing clear arguments and explanations for new product licences and licence renewals;- Preparing submissions of licence variations and renewals to strict deadlines;- Monitoring and setting timelines for licence variations and renewal approvals;- Working with specialist computer software and resources;- Ensuring regulatory compliance of product labels and patient information leaflets;- Advising scientists and manufacturers on regulatory requirements;- Providing strategic advice to senior management throughout the development of a new product;- Project managing teams of colleagues involved with the development of new products;- Undertaking and managing regulatory inspections;- Reviewing company practices and providing advice on changes to systems;- Negotiating with regulatory authorities for marketing authorisation;- Specifying storage, labelling and packaging requirements. Show less

  • Regulatory Affairs Associate Manager

    Jan 2022 - Apr 2025

  • Senior Regulatory Affairs Specialist

    Dec 2018 - Dec 2021

  • Regulatory Affairs Officer

    Jan 2014 - Nov 2018
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  DKSH

  Apr 2025 - now

  Regulatory Affairs Manager & Responsible Person for Pharmacovigillance