Anggi T.

Experience

• 

  PT Kimia Farma Apotek

  Jan 2015 - Jan 2015

  Pharmacist Intern

  Placement in Apotek Kimia Farma No. 2 Jakarta Pusat.Job description:- Do a prescription service.- Help to manage medicine stocks.- Check and confirm incoming goods from Business Manager Jaya II.- Help to carry out administrative tasks.- Other activities based on Good Pharmacy Practice (GPP).

• 

  PT Kalbe Farma, Tbk

  Mar 2015 - Apr 2015

  Quality Assurance Intern

  Placement in Quality Assurance (QA) Department.Job description:- Create process validation protocol and report.- Create a sampling plan for product post-marketing stability test.Project:Create a matrix for machine critical parameter for each products.

• 

  PT Kimia Farma Trading & Distribution

  May 2015 - May 2015

  Pharmacist Intern

  Placement in Jakarta-2 Branch.Job description:- Take the products in the warehouse based on invoice.- Create and send the distribution report of narcotics, psychotropics, and precursors to the national regulatory authority (NRA).Project:- Create a design of product placement in the warehouse.

• 

  Novell Pharmaceutical Laboratories

  Sept 2015 - Sept 2017

  Business Development & Registration Executive

  Manage product planning, registration, and launching of new drugs, generic drugs, and health supplements.Main scope:Regulatory affairs; business developmentJob description:- Generate, develop, and communicate new ideas about new innovative and prospective products.- Review drug-related patents in all aspects (molecular structure, formulation, strength, dosage form, indications, etc.).- Obtain import licenses (special access scheme) from the national regulatory authority (NRA).- Obtain approval of protocol of bioequivalence study from the NRA.- Represent the company as bioequivalence study monitor.- Monitor the progress of new product development.- Recapitulate pre-clinical and clinical trial data from published papers as supporting documents for regulatory submission of new drugs.- Prepare and review the regulatory dossier for new drugs and generic drugs.- Coordinate with marketing team and manufacturing team to prepare new product launches. Show less

• 

  Mundipharma

  Sept 2017 - May 2018

  Regulatory Affairs Officer

  Manage registration of all BETADINE® products and other consumer healthcare products, covering the categories of drugs, health supplements, cosmetics, medical devices, and household-health products.Job description:- Ensure full regulatory compliance to all local and international regulations, codes, and standards.- Prioritize assignments and implement regulatory plan and coordinate multiple projects and activities in accordance with company objectives.- Review, analyze, and coordinate data for new product submissions, line extensions, variations to marketed products, and responses to deficiency letters.- Review product information, labeling artworks, and other documentation as required for regulatory compliance.- Maintain the registration of marketed products. Show less

• 

  PT Darya - Varia Laboratoria Tbk

  May 2018 - Jun 2023

  Regulatory Affairs Supervisor

  Manage registration of new drugs and generic drugs.Job description:- Prepare, review, and submit new regulatory dossier of new drugs and generic drugs- Maintain the registration of existing products- Monitor registration process until approval is obtained in a timely manner- Ensure that all regulatory activities (product information, new product application, renewal application, variation application, clinical trial/bioequivalence study applications, etc.) are compliant with local regulations- Coordinate with cross-functional departments- Provide assistance to phase-in/phase-out management for all products from regulatory side. Show less

• 

  Bayer

  Jun 2023 - now

  Associate Regulatory Affairs Manager

  Manage registration of all consumer healthcare products but not limited to ASPIRIN®, BAYCUTEN®, BEPANTHEN®, CANESFRESH®, CANESTEN®, CDR®, SARIDON®, TONIKUM BAYER and UPIXON®, covering the categories of drugs, health supplements, quasi drugs, and cosmetics.Job description:- Determine local regulatory strategies and manage operational tasks for the consumer health (CH) portfolio, coordinating with local functions and other regional/global regulatory units.- Compile local submission files based on documentation from global regulatory partners and present them to authorities, ensuring timely submission/approval with optimal labeling.- Conduct regulatory assessments, providing recommendations on regulatory feasibility.- Implement change management activities with other functions and global regulatory affairs (RA).- Track local implementation of labeling changes based on the company core data sheet (CCDS) and standard operating procedures (SOP).- Provide information on RA milestones and documents for the global database, marketing authorization applications (MAAs), and variations.- Maintain and renew product licenses in compliance with global standards and local regulations.- Support the labeling review process for promotional materials, providing up-to-date labeling for marketing and medical use.- Liaise with the manufacturing site to support key RA projects and complete all RA-related tasks as per SOP.- Represent Bayer to local health authorities in all regulatory matters, enabling timely approvals with optimal labels.- Shape the regulatory environment by participating in industry association groups. Show less