ANA CARBALLO

Experience

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  Eusebio Martín Domínguez´s Pharmacy

  Mar 2011 - Jan 2013

  Pharmacist

  Key responsibilities:• Ensured that all prescription dispensing adhered to local and national regulations, including the verification of receipts prior to submission to the Spanish health authorities.• Provided expert advice on the safe and effective use of cosmetics, nutritional supplements, and personal care products to consumers.• Managed the reception of new shipments, ensuring proper documentation and regulatory compliance in inventory management.

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  Herran-Murillo C.B´s Pharmacy

  Feb 2013 - Jan 2014

  Pharmacist

  Key responsibilities:• Advising customers on cosmetics, nutritional supplements and personal care products.• Dispensing prescriptions and selling over-the-counter medicines. • Assisting customers face to face and on the phone.• Reception of new shipments and placement of the stock in the designated areas.• Stock control.• Revising receipts prior to submission to the correspondent health authority.

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  Julia Sánchez-Escribano´s Pharmacy

  Feb 2014 - Dec 2017

  Pharmacist

  Key responsibilities:• Ensured that all prescription dispensing adhered to local and national regulations, including the verification of receipts prior to submission to the Spanish health authorities.• Provided expert advice on the safe and effective use of cosmetics, nutritional supplements, and personal care products to consumers.• Managed the reception of new shipments, ensuring proper documentation and regulatory compliance in inventory management.

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  CEDE´s Academy

  Jan 2018 - Mar 2019

  Teaching assistant/science writer

  Key responsibilities:• Authored comprehensive scientific reviews on a wide array of scientific topics, including pathology, physiology, immunology, laboratory techniques, and nutrition.• Communicated complex scientific concepts in a clear, concise, and accessible manner.• Created study materials that met both the authorities’ requirements and the company’s guidelines.

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  Maria Felisa Moral Turiel´s Pharmacy

  Apr 2019 - Jul 2019

  Pharmacist

  Key responsibilities:• Ensured that all prescription dispensing adhered to local and national regulations, including the verification of receipts prior to submission to the Spanish health authorities.• Provided expert advice on the safe and effective use of cosmetics, nutritional supplements, and personal care products to consumers.• Managed the reception of new shipments, ensuring proper documentation and regulatory compliance in inventory management.

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  Julia Sanchez-Escribano´s Pharmacy

  Jul 2019 - Aug 2019

  Pharmacist

  Key responsibilities:• Ensured that all prescription dispensing adhered to local and national regulations, including the verification of receipts prior to submission to the Spanish health authorities.• Provided expert advice on the safe and effective use of cosmetics, nutritional supplements, and personal care products to consumers.• Managed the reception of new shipments, ensuring proper documentation and regulatory compliance in inventory management.

• 

  CEDE´s Academy

  Sept 2019 - Dec 2019

  Teaching assistant/ science writer

  Key responsibilities:• Authored comprehensive scientific reviews on a wide array of scientific topics, including pathology, physiology, immunology, laboratory techniques, and nutrition.• Communicated complex scientific concepts in a clear, concise, and accessible manner.• Created study materials that met both the authorities’ requirements and the company’s guidelines.

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  Inter Scientific

  Mar 2020 - now

  Key responsibilities:o Authored and revised regulatory documents, including Type II Drug Master Files (DMFs) and Marketing Authorization Application (MAA) sections (2.4, 2.6), ensuring compliance with the applicable International Conference Harmonization (ICH), Food and Drug Administration (FDA) and the European Medicines Agency (EMA) guidelines.o Prepared regulatory submissions in Common Technical Document (CTD) format for PreMarket Tobacco Product Applications (PMTAs). o Developed Office of Science (OS) meetings and Tobacco Product Master Files (TPMFs). o Generated Cosmetic Product Safety Reports (CPSRs) and Master Safety Data Sheets (MSDS) for cosmetic products.o Monitored legislative changes for cosmetics, novel foods (EU and UK) and tobacco products (US).o Revised cosmetic Product Information Files (PIFs), labels and product claims.o Submitted cosmetic product notifications in the EU and the UK notification portals.o Coordinated e-cigarette product notifications to the UK and the EU.o Conducted gap analyses for novel food applications in the EU.o Conducted clinical and nonclinical literature reviews, synthesising complex scientific.o Performed toxicological assessments and calculated Permitted Daily Exposure (PDE) levels.o Analysed and interpreted laboratory findings to support tobacco product submissions.o Provided training and mentorship; engaged with regulatory bodies and clients to align on goals and timelines.o Planned and executed regulatory projects, ensuring timely submission of high-quality regulatory documents.o Authored Standard Operating Procedures (SOPs) to standardise internal processes to support regulatory submissions.o Developed technical content for the company blog. Show less Key responsibilities:o Prepared regulatory submissions in Common Technical Document (CTD) format for PreMarket Tobacco Product Applications (PMTAs). o Developed Office of Science (OS) meetings and Tobacco Product Master Files (TPMFs). o Generated Cosmetic Product Safety Reports (CPSRs) and Master Safety Data Sheets (MSDS) for cosmetic products.o Monitored legislative changes for cosmetics, novel foods (EU and UK) and tobacco products (US).o Revised cosmetic Product Information Files (PIFs), labels and product claims.o Submitted cosmetic product notifications in the EU and the UK notification portals.o Coordinated e-cigarette product notifications to the UK and the EU.o Conducted gap analyses for novel food applications in the EU.o Conducted clinical and nonclinical literature reviews, synthesising complex scientific.o Performed toxicological assessments and calculated Permitted Daily Exposure (PDE) levels.o Analysed and interpreted laboratory findings to support tobacco product submissions.o Led the regulatory team in planning and executing projects, ensuring timely submission of high-quality regulatory documents.o Provided training and mentorship; engaged with regulatory bodies and clients to align on goals and timelines.o Authored Standard Operating Procedures (SOPs) to standardise internal processes to support regulatory submissions.o Developed technical content for the company blog. Show less

  • Regulatory Affairs Specialist

    Jan 2023 - now

  • Regulatory Affairs Manager

    Mar 2020 - Jan 2023