Local regulatory affairs specialist (freelance, spain)

Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.

We are looking for a Local Regulatory Affairs in Spain to join our team on a freelance basis for a long-term partnership. This is a fully remote position; however, residency in Spain and fluency in the Spanish language are required to fulfill the responsibilities.

Main Responsibilities

• Act as the local Regulatory Affairs representative; communicate with regulatory authorities regarding pre-submission strategies, regulatory pathways, compliance requirements, and submission follow-ups.
• Serve as the primary contact and subject matter expert for regulatory affairs, advising internal teams and external clients on local regulatory requirements.
• Support the preparation and submission of regulatory applications, including new marketing authorisation (MA) applications, variations, renewals, MA transfers, and related correspondence. Submit national declarations and notifications as required.
• Compile and maintain regulatory documentation and databases, track life-cycle submissions, and oversee regulatory duties for the assigned product portfolio.
• Translate and revise product information (e.g., Summary of Product Characteristics, Package Leaflet).
• Validate artworks to ensure compliance with the marketing authorisation and local legislation.
• Review promotional materials for regulatory compliance.
• Advice on launch requirements.
• Manage AEMPS portal.
• Support with labeling exemptions and consultations regarding orphan medicines supply.
• Work within clients’ systems.

Requirements:

• University degree in medicine, pharmacy, life sciences, or a related field.
• Experience regulatory affairs working with pharmaceuticals (minimum 2 years)
• Fluent in Spanish and English, both written and spoken.
• Strong knowledge of local regulations and requirements.
• Attention to detail
• Focused on quality and productivity
• Customer-oriented

Why join us

• Engaging, dynamic and diverse work in a young and rapidly growing company.
• International and multicultural environment.
• A workplace where your input matters and has an impact.
• Broad opportunities for self-expression and professional growth.
• Remote work