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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Primary Job Function/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.
Main Resposibilities:
- 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 (AMS) 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 Cluster North, for the specialty care portfolio.
Position Accountability / Scope
- This position must guarantee that all documentation and regulatory process are according to local regulations and AbbVie corporate policies.
- To support the documentary and technical information for tenders, customer service in North Region, for the portfolio.
- This position must represent to Region North as SME for corporate and local regulatory tools.
- Dossier preparation.
Qualifications
- Bachelors in Pharmacy, chemical engineering, or related education.
- Two years minimum of experience in pharmaceutical industry within quality assurance or regulatory activities
- Advanced English Level
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html