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Emma González

@emmagonzalez

Regulatory Affairs Expert at Galenicum Vitae, preparing pharmaceutical submissions across AMEA and supporting product lifecycle management.

Spain

Message

What I'm looking for

I am seeking remote regulatory roles where I can lead dossier preparation, manage variations and collaborate cross-functionally in a compliant, quality-driven environment.

At Galenicum Vitae, I define and execute regulatory strategies for pharmaceutical submissions across the AMEA region. I compile dossiers, publish submissions, and manage regulatory documents in line with local, ASEAN, and ICH guidelines.

I support CMC activities by drafting technical arguments and scientific justifications for new product licenses, and I prepare variations and renewals as part of product lifecycle management. I also contribute to the QMS by evaluating change controls through Quality Forward.

Previously, at Brill Pharma, I prepared technical documentation for medicinal products, medical devices, cosmetics, and food supplements. I worked with Spanish and Portuguese agencies, reviewed labeling and promotional materials, and supported pharmacovigilance, complaint handling, and QMS activities.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Expert

Current

Galenicum Vitae

Jun 2025 - Present (1 year 4 months)

Define and execute regulatory strategies for pharmaceutical product submissions across the AMEA region, managing dossier compilation, submission publishing, and document management. Collaborate cross-functionally to secure marketing authorizations and support CMC activities.

Regulatory Strategy Dossier Compilation Publishing Document Management CMC ICH Guidelines ASEAN Guidelines Product Lifecycle Management Variants Renewals QMS Change Control Quality Forward Labeling Patient Information Sheet

Regulatory Affairs & Quality Assurance

Brill Pharma

Jan 2024 - Jun 2025 (1 year 5 months)

Prepared and maintained technical documentation for medicinal products, medical devices, cosmetics, and food supplements. Monitored regulatory changes and liaised with Spanish and Portuguese agencies, managing labeling, complaints, and pharmacovigilance activities.