Publicada el Publicado hace 8 hr horas
Misión del puesto
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.
Obtenga más información sobre este puesto leyendo los detalles a continuación y luego envíe su solicitud para ser considerado.
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. xkdbapo
- Broad opportunities for self-expression and professional growth.
- Remote work
