2018
BS Pharmacy
Centro Escolar University
More About Me
Milca here, your Versatile VA who will make you feel a VVIP!
Being a pharmacist who places a strong emphasis on details and documentation allows me to enhance and use my medical background while also gaining competence that help me contribute to the growth, stability, and sales of the company.
I’ve been handling regulatory affairs and international business development matters from licensing, sourcing, product registrations, variations, compliances, pharmacovigilance, importations to distributions of pharmaceutical products (prescription, OTC, monitor release and biologicals) as well as food and medical devices (CMDN/CMDN).
I provide assistance and services to both start-up and existing local companies and foreign pharmaceutical manufacturers/exporters who wants to venture and extend their business in the Philippine market.
I am equipped with interpersonal and technical skills — which I developed while performing management, regulatory, and professional activities over the years. As I put my skills to use and obtain functional experience, I am always ready for challenges, new discoveries and improvements.
Try me now! 😉
Top Skills
Content Writing
Lead Collection
Email Marketing
Regulatory Affairs Communication and Compliance
International Business Development
Standard Operating Procedure (SOP)
Common Submission Dossier Template (CSDT)
Asean Common Technical Dossier (ACTD)
Certificates
My Experience and Education
2021
-
Present
Dreamax Incorporated
(Regulatory Affairs Head)
1. Oversees the operation of the company on a day to day basis.
2. Formulates and reviews SOPs for approval by the Business Development Manager and President.
3. Drafts regulatory and warehouse forms to be used on a daily basis by the concerned department.
4. Ensures that all the products, whether pharmaceutical or not, has the necessary permit/s with the concerned regulatory agencies.
5. See to it that the products carried by the company is purchased from licensed and GMP accredited manufacturers/suppliers.
6. Initiates and facilitates foreign communications.
7. Attends local and international conventions to find new sources.
8. Facilitates meetings with foreign manufacturers and other relevant companies.
9. Reviews and discuss agreement draft before finalizing and signing.
10. Requests, receives and evaluates foreign GMP documents and prepares the same for submission to Food and Drug Administration.
11. Attends to all FDA and other regulatory matters of the company including, but not limited to:
• LTO Initial and Renewal Application
• Checking Local Permits validity
• Product Registration – Drugs, Medical Device, Food and Cosmetics
• Renewal, Major and Minor Variation and/or Amendments
• Batch Certification / Notification
• Lot Release Certificate
12. Updates the president of the regulatory status every week accompanied by a progress report.
13. Monitors e-portal and eservices applications.
14. Evaluates Food, Medical Device and ACTD dossiers before submission to Food and Drug Administration.
15. Cross-checking of revisions given by the supplier based on our initial evaluation.
16. Maintains files of all transaction with all private and government agencies for future reference.
17. Maintains all file/record of all activities performed for future reference.
18. Maintains all records, reports and checklist from different departments on a quarterly basis, a summary master file and secures a back-up filing system.
19. Inspects and evaluates all purchased goods according to approved specification prior to acceptance and distribution.
20. Authorizes acceptance of shipments and release of products for local distribution.
21. Maintains Batch Distribution Record of all the products being distributed / offered for sale.
22. Sees to it that the labeling / packaging materials used for the product conforms to FDA requirements.
23. Sees to it that all antibacterial preparations had been subjected to Batch Certification and Batch Certificates had been released prior to distribution.
24. Processes product complaints received according to specified / standard operating procedure.
25. Attends to all product recalls as per the company’s standard operating procedure with utmost urgency.
26. Conduct a quarterly Self-Inspection with the Regulatory Affairs Officer, recommends and documents the inspections done.
27. Oversees the quantitation for Retention Samples.
28. Ensures compliance of the company to inspections conducted by regulatory authorities.
29. Coordinates and reports to Business Development Manager in regards to regulatory status.
30. Supports and provides bidding requirements to Bidding Department.
31. Assist Admin Department in filing and monitoring company operation.
32. Prepares and signs certifications requested by Local Distributors.
33. Interviews, trains and supervises newly-hired Regulatory Affairs Officer.
34. Delegates task to all Regulatory Department members.
35. Other duties and responsibilities that may be assigned by the immediate superior or manager.
2020
-
2021
Pharma-surrey International Inc.
(Regulatory Affairs Officer)
1. Oversees the operation of the company on a day-to-day basis.
2. Makes sure that all the products, whether pharmaceutical or not, has the necessary permit/s with the concerned regulatory agencies.
3. Represents the company as Qualified Authorized Personnel
4. Initiates and maintains communication with the Foreign Sources including review of Distribution Agreement, preparation of Product Forecast and review of prices and MOQs.
5. Attends to all FDA and other regulatory matters of the company including, but not limited, to LTO Permit / Permit Registration / Renewal, Batch Certification / Notification, Product Registration, Variation or Amendment Application, etc.
6. Prepares Company SOPs based on Regulatory Guidelines.
7. Maintains Batch Distribution Record of all the products being distributed / offered for sale.
8. Submit EDPMS report quarterly.
9. Review of ACTD Dossier, Food and Medical Device requirements.
10. Sees to it that the labeling / packaging materials used for the product conforms to FDA requirements.
11. Sees to it that all antibacterial preparations had been subjected to Batch Certification and Batch Certificates had been released prior to distribution.
12. Processes product complaints received according to specified / standard operating procedure.
13. Attends to all product recalls as per the company’s standard operating procedure with utmost urgency.
14. Conducts quarterly Self-Inspection, recommends, and documents the inspections done.
15. Applies for application of GMP Clearance for foreign suppliers.
16. Oversees the quantitation for Retention Samples.
17. Prepares the documents needed for inspection conducted by regulatory authorities.
18. Attends local and international pharmaceutical events to source new manufacturers/traders and FDA seminars to ensure knowledge of updated guidelines.
19. Other duties and responsibilities that may be assigned by president.
2019
-
2020
Altheamed Pharmaceuticals Inc.
(Regulatory Affairs Officer)
1. Oversees the operation of the company on a day-to-day basis.
2. Makes sure that all the products, whether pharmaceutical or not, has the necessary permit/s with the concerned regulatory agencies.
3. Represents the company as Qualified Authorized Personnel
4. Initiates and maintains communication with the Foreign Sources.
5. Attends to all FDA and other regulatory matters of the company.
6. Review of Medical Device requirements before application submission.
7. Prepares the documents needed for inspection conducted by regulatory authorities.
8. Other duties and responsibilities that may be assigned by president.
Consultancy and Outsource Services
Regulatory Affairs and Consultancy
Provides assistance regarding regulatory concerns, from licensing to registrations.
Lead Generation/Email Marketing
Convert a stranger to a client and boost your future sales.
Medical Virtual Assistant
Provides excellent patient care while also handling day-to-day operational tasks
International Business Development
Connects and negotiates to potential suppliers and business partners to strengthen the core of your business.