Regulatory Affairs Specialist
AbbVieBogotáUpdate time: December 3,2021
Job Description
About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Mission: Put in place the strategic vision through the development of regulatory dossiers as subject matter expert (SME) assuring the correct and clear information across the process. Influencing the regulatory environment with a clear purpose to achieve, that includes, regulatory timelines, evaluation, and approval, avoid deficiency letters, increase understanding of product information. Assure internal regulatory processes, to be accurate and on time for audit processes. Core Job Responsabilities: Preparation of state-of-the-art regulatory dossiers, according to product regulatory strategy previously aligned. Tend to look always for a first pass approval from the health authorities. In case any inquire, assure a timely and accurate response as well as look for learning, avoiding same inquiries in future regulatory processes. Responsible for safety information update contained in the local labeling of products marketed in North Region according to AbbVie policies and local regulations (CCDS Management). Update the local and global platforms of regulatory affairs in accordance with the submissions and prepared dossiers executed by this position. Coordinate and execute the review, harmonization, and approval (PPLS) of labeling associated to commercialized products prior to its implementation in accordance with applicable global and local policies. To follow up resolutions and concepts issued by regulatory entities, related to regulatory procedures, as well as the review of approvals, according to the submissions executed by this position. Review and approve promotional and non-promotional material, as assigned to this position. Administrate the promotional and non-promotional materials tool. Actively participate in regulatory and other related meetings with key business stake holders, providing the necessary regulatory support. Provide documentary and technical support to tenders, customer service in North Region, for the Eye Care portfolio. Qualifications: Advanced English Level. +5 years of experience working in pharmaceutical industry in qulaity or regulatory activities. Bachelor's degree. Qualifications Mission: Put in place the strategic vision through the development of regulatory dossiers as subject matter expert (SME) assuring the correct and clear information across the process. Influencing the regulatory environment with a clear purpose to achieve, that includes, regulatory timelines, evaluation, and approval, avoid deficiency letters, increase understanding of product information. Assure internal regulatory processes, to be accurate and on time for audit processes. Core Job Responsabilities: Preparation of state-of-the-art regulatory dossiers, according to product regulatory strategy previously aligned. Tend to look always for a first pass approval from the health authorities. In case any inquire, assure a timely and accurate response as well as look for learning, avoiding same inquiries in future regulatory processes. Responsible for safety information update contained in the local labeling of products marketed in North Region according to AbbVie policies and local regulations (CCDS Management). Update the local and global platforms of regulatory affairs in accordance with the submissions and prepared dossiers executed by this position. Coordinate and execute the review, harmonization, and approval (PPLS) of labeling associated to commercialized products prior to its implementation in accordance with applicable global and local policies. To follow up resolutions and concepts issued by regulatory entities, related to regulatory procedures, as well as the review of approvals, according to the submissions executed by this position. Review and approve promotional and non-promotional material, as assigned to this position. Administrate the promotional and non-promotional materials tool. Actively participate in regulatory and other related meetings with key business stake holders, providing the necessary regulatory support. Provide documentary and technical support to tenders, customer service in North Region, for the Eye Care portfolio. Qualifications: Advanced English Level. +5 years of experience working in pharmaceutical industry in qulaity or regulatory activities. Bachelor's degree. Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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