Freelancer profile translated to English.
Back to original languageAbout Andreia
10 years of experience in regulatory affairs, in the pharmaceutical and medical device industry. I have had the opportunity to collaborate with several companies (from start-ups to large groups).
Regarding my areas of expertise, I specialize in international registration (various regions: Latin America, Asia, Africa, USA, Canada, Switzerland).
I also have experience in all phases of market access:
- Requirements for formulation phases;
- CMC writing (module 3) / technical files;
- Responses to authorities' questions;
- Lifecycle management (variations/renewals);
- Clinical trial submissions;
- Change control management;
- Process improvement;
I prefer short-term, part-time assignments.
Available in the Compiègne (60) region, or remotely.
French
Native or bilingual
English
Fluent
Portuguese
Native or bilingual
Spanish
Conversational
Remote only
Primarily works remotely
Experience
- Bausch & LombCustomer Service Specialist - Spain & PortugalPHARMACEUTICALS INDUSTRYMay 2025 - Today (1 year and 1 month)Montpellier, France- Management of customer orders (cataract implants)- Invoicing (hospitals and mutual insurance companies)- Quadrilingual commercial assistance (Spanish, Portuguese, French, and English)
- SANOFIRegulatory Affairs CMC ExpertJanuary 2022 - October 2022 (9 months)Compiègne, FranceSupport for the development of OTC products (solid forms) CMC writing
- FreelanceRegulatory Affairs SpecialistJuly 2019 - November 2021 (2 years and 4 months)Client: Laboratoire de la Mer (Saint-Malo, France): Registration of Class I, Is, IIa Medical Devices in Australia, Ukraine, Saudi Arabia, UK. Client: Nourishe Organics (USA) - Labeling Review Review of labeling and creation of IFUs for organic cosmetic products Mastery of guidelines: "FDA Guidelines for Cosmetics" and "USDA Guidelines for Organics" Cosmetics Claims Client: Microblading Academy (USA) - European Regulatory Strategy Registration Strategy for Cosmetics in the EU and US Client: Danidean (UK) - Classification of Medical Devices Europe Classification of Medical Devices according to the "EU regulation 2017/74 (MDR)" Distributor responsibilities in terms of compliance
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Education
- Master 2 in Industrial Pharmacy specializing in Drug Regulatory AffairsFaculty of Pharmacy of Montpellier2012Master 2 Pharmacie Industrielle spécialisé en Affaires Réglementaires du Médicament
- Bachelor's Degree in Biology, Molecular and Cellular Biochemistry trackUniversity of Science and Technology of Languedoc (Montpellier II)2010Licence Biologie Parcours Biochimie Moléculaire et Cellulaire