miriam ojeda

Manage regulatory processes to obtain and maintain European and non-European marketing authorizations, leading CMC post-approval and pre-MA activities and delivering technical dossier writing and maintenance for multiple clients, improving dossier compliance and timelines.

Ensured regulatory compliance between manufacturing operations and regulatory documentation by writing/reviewing variation dossiers and Module 3 content, coordinating cross-functional teams to deliver regulatory submissions on schedule.

Managed national phase submissions and prepared/reviewed SPCs, PILs and labelling while liaising with national health authorities and adapting texts following referrals to ensure regulatory alignment across markets.

Reviewed and translated Type 1 and Type 2 variations and Quality Module 3, and prepared compilation and submission of renewals to maintain product registrations.

Provided dietetic advice and nutritional counselling to clients, managing individualized diet plans and supporting customer health goals.

Contributed to genetic and microbiology research projects, supporting DNA sequencing service operations and laboratory investigations.

Activities and societies: Clinical rotations, genetic counseling of patients and families

Completed a Master Degree in Genetic Counselling with clinical rotations including Children's National Medical Center (Washington DC) and major hospitals in Barcelona.

Completed a Master Degree focused on the Pharmaceutical Industry covering regulatory and industry-relevant topics.

Activities and societies: Collaborator in experimental investigation and DNA sequencing service

Completed a Degree in Biochemistry with coursework and research experience in molecular techniques.

Activities and societies: Research collaboration in Genetics and Microbiology departments

Completed a Degree in Biology with laboratory and research experience within the Genetics and Microbiology departments.