Especialista De Asuntos Regulatorios

Job Description / Capsule:
Plan and execute regulatory activities in order to support AstraZeneca operations, projects and objectives while maintaining in compliance with company policies, local regulations and quality and ethical standards.

Typical Accountabilities:

- Prepare regulatory submissions to the Heath Authority
- Participates cross functionally
- Guarantee the timely updating of the databases and corporate tools of the products
- Get involved in the regulatory environment
- Review and work according to SOPs
- Keep updated in ANGEL the information of submissions to COFEPRIS
- Change controls in OCM
- Keep updated in Gazelle the labels

Education, Qualifications, Skills and Experience:

- Professional degree
- Knowledge of health care regulations, laws and standards
- Analytical, written and oral communications skills
- Ability to work effectively in a team
- Experience in pharmaceuticals or a related industry
- Advanced english level (80%)
- Minimum 3 years experience in a similar rol