Job Description
**Basic Functions & Responsibility (may not be limited to)**:
- For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
- Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of CMC variations, non-CMC variations, renewals, OMA, according to the Mexican Regulation, in cooperation with RAI Liaison, iCMC and other internal stakeholders as applicable.
- For assigned products and tasks, stays updated on late our company pipeline filings, relevant local regulations, and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- For assigned products and tasks, works alongside the BD, locally and regionally to support bu...
- For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
- Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of CMC variations, non-CMC variations, renewals, OMA, according to the Mexican Regulation, in cooperation with RAI Liaison, iCMC and other internal stakeholders as applicable.
- For assigned products and tasks, stays updated on late our company pipeline filings, relevant local regulations, and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- For assigned products and tasks, works alongside the BD, locally and regionally to support bu...
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