Spclst, Regulatory Affairs
hace 4 meses
The proposed functions for the FTE ( Colombia - Ecuador ) are:
**Colombia**
- Champion promotional/non promotional materials.
- Maintenance of Life Cycle Management of the established products and transversal support within the area.
- RA Champion of the RADR system - Colombia.
- Management of archiving process in Veeva RIM within the established deadlines.
- Interaction with the HA and PAC according with the Decree 334.
**Ecuador**:
- Renewal of GMPs/CPPs required by RA Ecuador
- Tender support: Management of GMP/CPP translation process
- Support the GMPs Registration process.
- RDAR champion for Ecuador (responsible for archiving process and process dispatches of the complete portfolio in Ecuador)
- Labeling champion for Ecuador
- Pharmacovigilance Report Assessment
- Maintenance of Life Cycle Management (The submission process in the HA system is not included due to technical limitations and token restrictions. This will be managed locally)
- Transversal support within the area in case of new projects, task and others.
**Secondary** Language(s) Job Description**:
**Qualifications**:
- Bachelor’s degree in Pharmacy required.
**Experience**
- 2 years of experience in the pharmaceutical industry, with the most recent 6 months at RA Colombia and a total of 10 months in the Regulatory Affairs area. Prior experience in quality control (QC) is preferred.
- Fluent English - speaking, writing, reading recommendable
- Ability to communicate effectively, both verbally and in writing, with individuals at all levels of the organization.
- Knowledge in local regulations general and specific for drugs, small molecules, and biologics
- Management internal platforms/programs for regulatory activities.
- Good organizational skills with the ability to effectively manage multiple activities across various projects simultaneously.
**Skills**
- Demostrate ethics and integrity.
- Detailed orientation.
- Focus on the pacient.
- High capacity in problem solving.
- Competitive decisión making.
- Operational and comercial management.
- Effective communication.
- Effective execution capacity.
- Sense of urgency, initiative.
- Strategic Thinking
- Develop talent.
- Regulation and management compliance.
- Data analysis and interpretation.
- Collaboration, teamwork.
- Leadership.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R291376
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