Head Regulatory Affairs Mexico, Centralamerica and Carribean en BOEHRINGER INGELHEIM

Head Regulatory Affairs Mexico, Centralamerica and Carribean
BOEHRINGER INGELHEIM | (3) ofertas activas
México DF, 21 Oct.
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Descripción
The position
Lead regulatory affairs team in Mexico & CAMCAR aligned with global and regional strategies and compliance requirements, ensuring the timely and successful submissions and regulatory compliance of Boehringer Ingelheim's portfolio in the OPU.



Tasks & Responsibilities

1. Lead regulatory affairs regional team aligned with global and regional strategies by:
- Ensuring timelines and aligned strategy for new submissions in Mexico and CAMCAR countries.
- Sharing best practices within the OPU.
- Providing timely and concise input to global RA concepts/strategies/projects.
- Representing the region on global RA.
2. Lead regulatory inteligence consolidation, impact assesment and communication process.
3. Registration oversight (Overview of new submissions,planned approvals, product maintenance topics/issues).
4. Ensure adherence to BI and international compliance rules as well as to local legislations in all areas of Regulatory Affairs in the OPU by:
-Supporting local inspection readiness.
-KPI Monitoring, Tracking & Reporting.
5. Support and input for, and to, the regulatory departments/groups of the countries ensuring appropiate training for OPU is in place.
6. Participation in Market Access alignment & Support/ alignment with Clinical Organizations at OPU level.

Numero de vacantes: 1
Tipo de contrato: Indefinido

Ventajas sociales o económicas
We also offer a competitive salary, numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym, best-in-class cafeterias and coffee bars to keep you energized and healthy and other various benefits and rewards. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
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Requisitos
Requirements:
- University scientific degree: Bachelor on Biologic sciences, Chemestry (QFB) or similar.
- Knowledge of local and international regulatory affairs regulation and Sanitary Regulations (OMS, RTCA, FDA, EMA, NOM, ICH, etc).
- Relevant experience in pharmaceutical industry/CRO: at least 7 years of experience in management and regional positions.
- Fluent English.

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
más de 10 años
Disponibilidad para viajar
El 20% del tiempo laboral



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