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 global 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 Health Authority.
• Ensure the dossier meets with the local requirements according to the corresponding regulations
• Execution of the activities required for the Subcommittee of Evaluation of Biotechnology Products & New Molecules Committee presentation.
• 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 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[SCAL1]  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.[SCAL2] 
• Review of advertising and promotional material in Veeva and submission to Cofepris.
• Prepare, submit and obtain the approval for local biological product release.
• 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.

Position Accountability / Scope

Maintain budget control.

Internal areas of interaction: Sanitary responsible, Quality Assurance, Marketing, Medical, Pharmacovigilance, Demand, Market Access, AREA Regulatory, this list is enunciative and not limitative, any other interaction area required may be included in the scope.

External Areas:

Mexican National Regulatory Agency (COFEPRIS), industry associations (CANIFARMA, AMIIF) and A&AS Area (Area and Affiliate Support)