Regulatory Affairs Specialist - #7355263

AbbVie


Fecha: hace 2 semanas
ciudad: Bogotá, Bogotá D.C.
Tipo de contrato: Medio tiempo

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Ready to innovate together? We are looking for a Specialist, Regulatory Affairs in this position you will be 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. Generate continuous improvement through follow up to Regulatory vendors of processes associated to regulatory activities.


  • Preparation of state-of-the-art regulatory dossiers, according to product regulatory strategy previously aligned.
  • T end 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 of labeling associated to commercialized products prior to its implementation in accordance with applicable global and local policies.
  • T o 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 assigned portfolio.
  • Coordinate and do follow up to regulatory vendors to assure that all activities associated with regulatory process area carry out in time and properly according to internal policies and procedures

Qualifications


  • This position must represent to Region North as SME for corporate and local regulatory tools.
  • Dossier preparation.
  • Pharmacist, Chemical Engineering
  • At least two years working in pharmaceutical industry in qulaity or regulatory activities
  • English Mid to high level

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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