Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
Purpose
- Coordinate all the required activities with Area Therapeutic Area Teams and local stakeholders to ensure that the dossier content complies with local regulations to submit to the local Health Authority the required applications in order to obtain the marketing authorization for new products or the required variations or renewal.
- Coordinate all the required activities for label update based on reference label to submit to the local Health Authority according to KPIs timelines.
- Execute the review and approval process of advertising,



promotional and non-promotional materials in compliance with the applicable regulations and company policies.
- Coordinate all the required activities with Area Therapeutic Area Teams to ensure the availability GMPc issued by the local Health Authority for the applicable products/manufacturing sites.
- Control and guard of GMPs, CPPs, PoAs, LoAs, and other legal documents
- ADVERTISING Prepare the advertising application files for Cofepris submission and coordinate the submission dates with MKT.
- Update general regulatory systems in compliance with the timelines defined.

Responsibilities
- Review and validate the translation to Spanish of documents translated by Area and local translations.
- Coordinate the translation to Spanish of the technical, legal and/or clinical support documentation provided by global.
- Prepare, review and integrate the files for the submission to the local Hea

📌 Regulatory Affairs Coordinator (Ciudad de México)
🏢 Powertofly
📍 Ciudad de México