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
Job Mission:
Support the execution of regulatory strategies for all products, assuring the inclusion of the latest regulatory framework, to get final approval of Marketing authorization at the best timeline possible and according with AbbVie policies.
Ensure no significant business interruptions due to regulatory compliances issues. No market actions that impact patient safety. No critical observations from authority inspections /audits.
Job Responsibilities
- Maintain product license in compliance with market supply, and local authority regulations.
- Ensure alignment with all applicable SOPs
- Manage agency interactions for safety and compliance issues.
- Support local due diligence and Launch excellence process, within the required timelines to ensure the compliance of planned launching dates.
- Lead interactions with local regulatory authority as required, facilitating the review, responses to questions and approval of all local submissions in a timely manner.
- Completion of any post approval commitments.
- Provide Regulatory support for the timely submission of new drug applications.
- Review and approval of promotional materials.
- Lead all labeling harmonization / compliance processes, assuring KPIs results
Ensure the maintenance of databases
- Provide regulatory support for cross functional programs and activities e.g. pricing, reimbursement Activity, government bids.
- Ensure prescribing information, labels and other packaging components are in alignment with regulations and core safety information
- Participation in Regulatory Intelligence, anticipating new regulation and competitors activities
-Coordinate and support the regulatory activities to align them with all business needs
-No market actions that impact patient safety.
-No significant business interruptions due to RA and QA compliance issues
Qualifications
Bachelors in Pharmacy, Chemical Engineering and correlated areas;
5+ years of experience working within the pharmaceutical industry in quality and Regulatory activities covering small molecules and biologics. Medical devices management is a plus.
Good communication and negotiation skills.
Leadership Management skills.
Advanced English skills
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
