Regulatory Affairs Manager Jr

hace 4 meses

Tlahuac, México Zoetis A tiempo completo

**Role Description**

The Regulatory Affairs Manager Jr. (RAMJr.) will be responsible for executing the strategies previously defined by the RASrM, will also support the promotion of compliance, advising other Departments about local regulations (COFEPRIS, SADER and PROFECO) and global procedures. Together with the RASrM, will identify possible impacts of regulatory activities on other Departments.
- The RAMJr. will execute actions related to strategies determined by the RASrM, to be ready for regulatory impacts at Zoetis Mexico.
- The RAMJr. will review monthly objectives with the regulatory team and will propose alternative strategies to deal with variables presented during execution.
- The RAMJr. will identify development areas for the team, according to objectives previously defined.
- The RAMJr. will work together with the regulatory team reviewing the accuracy of information contained in mandatory reports.
- The RAMJr. will review files generated by the regulatory team, to ensure accuracy, veracity and compliance of information, conducting risk assessments if needed during the execution of this process.
- The RAMJr will oversee the accuracy of information contained in regulatory systems, will also measure parameters in order for the RASrM, to be able to identify improvement areas.
- The RAMJr will participate attending internal and external audits performed for quality or regulatory purposes.
- The RAMJr will document the regulatory expenses, to be evaluated by the RASrM to identify optimization opportunities of resources.
- The RAMJr will be the backup of the RAM if needed.
- The RAMJr will coordinate certification processes of devices.

**Responsibilities**:
The Regulatory Affairs Manager Jr. will be primarily responsible for the following activities which includes but is not limited to:

- Oversee the compliance of monthly objectives previously determined by the RAM, in order to accomplish approval dates of new registration processes, transfers and variations.
- Monitoring compliance of regulations and performing pre-verification reviews to predict possible observations and together with the RAM, identify a mitigation plan.
- According to priorities previously defined, the RAMJr. will support the team managing daily activities.
- Coordinate the execution of strategic plans, based on predictions of the RAM, to reduce regulatory impact at Zoetis Mexico.
- Monitoring the development of local artworks and creation of QNs, to accomplish deadlines previously defined and avoiding supply disruption of product commercialization. To perform this activity, the RAMJr. will periodically review information of products with Logistic and Demand team.
- The RAMJr. will review mandatory reports (SADER and COFEPRIS) to ensure traceability.
- Monitoring veracity and timely completion of information in systems: Veeva Vault, SAP and ETS (Event Tracking System).
- Performing regulatory verifications before SADER, COFEPRIS and PROFECO.
- Reviewing files generated by the regulatory team for submission purposes, including the review of advertising through a Verification Unit.
- Proposing solutions to solve queries of authorities to accomplish authorizations of files.
- Managing records of regulatory parameters including expenses and periods used to perform daily activities.
- Properly managing confidential documents based on global Zoetis procedures.
- Monitoring submission of pharmacovigilance events to ensure compliance with local regulation, corporate policies, guidelines and procedures.
- The RAMJr will identify the best strategy to certify devices according to local regulations.

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