Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
- 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 Health Authority.
- Ensure the dossier meets with the local requirements according to the corresponding regulations
- Give a close follow up to internal activities needed for the review & approval of administrative & technical variations.
- Develop the local labeling texts ensuring that they meet with local regulations, internal SOP and the reference document provided by the area.
- Drive labeling process for creating new or updating previous artworks for the pharmaceutical, biotechnological & biological products, as initiator and/or reviewer.
- Ensure that the GMPs and other legal regulatory documents of manufacturing sites are valid during the entire lifecycle of the marketing authorization. Applicable for documents issued by the local Health Authority or other regulatory agencies.
- Maintain the archive of the GMPs, CPPs, PoAs, LoAs, and other legal documents and maintain the control of the documents ensuring that the originals are kept and ensure there is always available at least one certified copy of each document and request new certified copies to the Administrative Assistant.
- Keep updated the tracking database and due dates for the request of the GMPs, CPPs, PoAs,
LoAs, and other legal documents to the GSSC. - Review of advertising and promotional material in Veeva and submission to COFEPRIS.
- Participate in the assigned meetings internally and externally.
- Execute all the activities described in alignment with AbbVie culture and philosophy.
- Keep updated the applicable SOP.
- Keep updated the global regulatory systems.
Qualifications
- Pharmacist, Biotechnology Engineer, Pharmaceutical Engineer or related demonstrable professional degree.
- Knowledge in Health regulation in Mexico. Experience with Medical Devices will be considered a Plus
- Good communication skills.
- Good relationships with internal stakeholders.
- Continuous tracking of self and other activities.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html