Global Regulatory Affairs Specialist

Freyr Solutions; México; Presencial; MXN 420.000 - 660.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Global exposure

International projects

Career growth

Descripción de la vacante

Freyr Solutions is seeking a Regulatory Affairs Specialist to manage regulatory submissions across assigned markets, ensuring compliance with local regulations and company SOPs. The role involves collaborating with cross-functional teams to support product registrations and lifecycle activities.

Ideal candidates have 5+ years in regulatory affairs or CMC, with a health/life sciences degree and fluent English.

Formación

• Excellent communication and time management skills.
• Ability to negotiate and influence management, affiliates and regulatory agencies.
• Fluent in English (written and spoken) and understanding of regulatory requirements.

Responsabilidades

• Assist in development of regulatory submission plans and communicate them across teams.
• Maintain regulatory documentation and archival systems per SOPs.
• Ensure compliance with local laws and company procedures for submissions.
• Support post-market variations, renewals, site transfers and importation activities.
• Identify procedural gaps and collaborate on CAPAs with stakeholders.

Conocimientos

Communication

Time management

Negotiation

Regulatory affairs

Educación

Bachelor's in Life Sciences

Descripción del empleo

Freyr Solutions is seeking a Regulatory Affairs Specialist to manage regulatory submissions across assigned markets, ensuring compliance with local regulations and company SOPs. The role involves collaborating with cross-functional teams to support product registrations and lifecycle activities.

Ideal candidates have 5+ years in regulatory affairs or CMC, with a health/life sciences degree and fluent English.