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Regulatory Affairs Specialist
hace 3 semanas
PURPOSE STATEMENT
The mission of the Regulatory Affairs Analyst is to cooperate with the Regulatory team in several activities related to the area. The primary goals are in providing support in registration of products for Oncology and new Specialty portfolio, labeling for Region South and the activities required to release product to the Argentinean market.
AJOR RESPONSIBILITIES (List up to 10 main responsibilities for the job. Include information about the accountability and scope):
ANMAT RELATED ACTIVITIES:
- Responsible for making the dossier preparation, presentation, and the submission with the Regulatory Body, for attestations and pharmaceutical plants certifications.
- Support the RA Team with regulatory processes such as new registrations, renewals, variations, manufacturing sites inspections. In addition to that, in charge of coordinating appointments with the Regulatory Body for submissions or retrieval of documents. Also, in charge of managing the follow-up of filings, to make sure they do not take longer than expected and are approved in accelerated timelines.
- ARTWORKS: Cooperate in the revision and development of artworks for the products commercialized in the region, assuring the quality control is in place.
- ARCHIVING: Maintenance of the updated, complete, and orderly physical/ electronic files for both Oncology and new Specialty portfolio.
- INTERNAL PROCEDURES: Co
- lead the review and update of applicable SOPs. Also participate in the update of local changes coming from global SOPs.
**EDUCATION**:
- Bachelor’s in pharmacy.
- Student pharmacy.
- Fluent Spanish and advanced English
**SKILLS**
- Good communication skills
- Good organizational skills
**EXPERIENCE**:
- Recommended 2 to 3 years in similar position.
- Recommended Knowledge of regulations
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