Local Regulatory Affairs Manager in Spain (Freelance / Part-time)

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

Local Regulatory Affairs Manager in Spain (Freelance/Part-time)

Freelance opportunity in Spain! Join our global team as a Local Regulatory Affairs Manager in Spain. The Local Regulatory Affairs Manager will be responsible for ensuring that medicinal and other products comply with applicable regulatory requirements by providing input and coordinating marketing authorization and post-authorization related activities. The position is remote (approximately 0.25 FTE) and covers Spain, working in close collaboration with the Regulatory Affairs team. Submit your CV in the English language for consideration.

Responsibilities

• Act as Local Regulatory Affairs Manager in the assigned territory.
• Maintain timely and effective communication with local Competent Authorities.
• Monitor and report changes in national regulatory requirements on a regular basis.
• Develop and/or review regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.
• Prepare regulatory documentation for submission to Competent Authorities. Regulatory submissions.
• Regulatory review for labelling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure full compliance with applicable regulatory requirements.
• Translations.
• Ensure accurate documentation, reporting, and follow-up of all regulatory reports.
• Support Biomapas clients with other RA-related tasks, including strategic and operational regulatory advice.

Requirements

• Biologist, Pharmacist, Medical Doctor, or other life science degree
• Fluent written and spoken English and Spanish
• At least 2 years of experience in local regulatory affairs activities
• Experience with local documents preparation and regulatory submissions
• Excellent knowledge of local and international regulations (including knowledge concerning orphan medicinal products and the market entry aspects of centrally authorized medicines)
• High motivation to develop and learn within the team

Nivel de antigüedad

Intermedio

Función laboral

Otro