Remote Local Regulatory Affairs Manager - Spain (Freelance)

Biomapas; España; A distancia; EUR 30.000 - 50.000; A tiempo parcial

Descripción de la vacante

A global regulatory affairs company is seeking a Local Regulatory Affairs Manager to ensure compliance with regulatory requirements in Spain. The role is freelance/part-time, remote, and requires a life science degree and fluency in English and Spanish. Responsibilities include handling communications with authorities and preparing submissions. Ideal candidates have at least 2 years of experience in regulatory affairs.

Formación

• Min 2 years of experience in local regulatory affairs activities.
• Experience with local documents preparation and regulatory submissions.
• Excellent understanding of orphan medicinal products and centrally authorized medicines.

Responsabilidades

• Act as Local Regulatory Affairs Manager in the assigned territory.
• Maintain communication with local Competent Authorities.
• Prepare regulatory documentation for submission to Competent Authorities.
• Support clients with other RA-related tasks.

Conocimientos

Fluent written and spoken English

Fluent written and spoken Spanish

Knowledge of local and international regulations

Experience in local regulatory affairs

High motivation to develop and learn

Educación

Biologist, Pharmacist, Medical Doctor, or other life science degree

Descripción del empleo

A global regulatory affairs company is seeking a Local Regulatory Affairs Manager to ensure compliance with regulatory requirements in Spain. The role is freelance/part-time, remote, and requires a life science degree and fluency in English and Spanish. Responsibilities include handling communications with authorities and preparing submissions. Ideal candidates have at least 2 years of experience in regulatory affairs.