Responsible for the registration and life cycle management of Gene Therapy, Orphan Drugs, and Oncology products. Experience in Pre-submission process: New Molecules Committe and New Drug Aplications. Ensure timely submissions of regulatory variations in compliance with corporate, local, and reference agency requirements. Identify submission components and pontential risks, request information from headquarters for dossier preparation and coordinate the assembly of regulatory dossiers. Lead the preparation, strategy, and submission of product registration modifications, and follow up with health authorities. Ensure product supply from a regulatory perspective. Maintain communication with cross-functional teams. Ensure procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedures.

Alignment and registration of safety data sheets for pharmaceutical ingredients and materials, ensuring compliance with NOM-018-STPS-2015 and international regulations. Responsible for updating Drug Master Files for active ingredients, and reviewing and updating specifications for active ingredients, excipients, and packaging materials. Oversee the implementation and adherence to ISO 9001:2015 quality management systems.

Molecular genetics of development and cell-cell interactions preventing self-fertilization in plants. Skilled in genetic engineering techniques and plant biotechnology. Faculty of Chemistry.

Provides effective operational and regulatory support to Novartis and global organizations for assigned regulatory submissions and maintenance activities. Responsibilities include preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives, artwork-related activities, and review of prescribing information