Regulatory Affairs Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia ABBVIE A tiempo completo

Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world.


We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset.

From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients' lives around the world.

In short, we know it takes you make those groundbreaking advancements happen.

  • Preparation of stateoftheart 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 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 nonpromotional material, as assigned to this position. Administrate the promotional and nonpromotional 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

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