Regulatory Affairs Sr. Specialist

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.

Primary Job Function/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.

Core Job Responsibilities

- Ensure correct management New Marketing Authorization and key strategic submissions across the portfolio in charge.

- Maintain product license in compliance with market supply, and local authority regulations.

- Ensure alignment with all applicable SOPs

- Manage agency interface for safety and compliance issues.

- Support local due diligence and Lex process, within the required timelines to ensure compliance of planned launch dates.

- 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 aligned with regulations and core safety information

- Participation in Regulatory Intelligence, anticipating new regulation and competitors’ activities.

Education

• Bachelors in Pharmacy, Chemical Engineering and correlated areas 
• Advanced English skills (Written and Spoken) 
• At least 4-5 years of experience working within the pharma industry in Quality and Regulatory activities. Consumer health care regulatory processes management is a plus.
• Good communication and negotiation skills.
• Leadership Management skills.

AbbVie is an equal opportunity employer and 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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