The main purpose of this role is to plan, direct, coordinate and oversee quality aspects of activities and duties of General (GRA) and Local Regulatory Affairs (LRA) teams.
This includes also the management and the coordination of quality of regulatory affairs pertinent to third parties.
A secod purpose of the role is the implementation, enhancement and maintenance of the company compliance framework, ensuring adherence to internal procedures as well as to national and international regulations.
The role will also be responsable for compliance of computer system validation with applicable references (e.g:21 CFR part 11 Annex 11, GAMP) and management of non-compliances based on GxP impact evaluation and risk assessment.
Número de vacantes: 1
Modalidad de trabajo: Presencial
Tipo de contrato: Indefinido
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**Requisitos**




Bachelor's degree in Life Sciences /Sciences/ Biomedical matters.
Strong Experience in management of Health Authorities Inspections and Third parties audits.
At least 8 years of relevant experience in Regulatory Affairs and Quality Assurance area.
Solid understanding of risk and compliance principles and frameworks.
Demostrated stakeholder engagement experience.
Abiliry to understand the impact of regulatory changes on the business.
Good English proficieny (B2 level is required)
Use computer tools
Estudios mínimos
Licenciado
**Idiomas**:
Inglés nível Perfecto.
Experiência mínima
de 5 a 10 años
Disponibilidad para viajar
El 20% del tiempo laboral

📌 Senior Global Compliance Regulatory (Colima)
🏢 Importante empresa
📍 Colima