Regulatory Affairs Manager

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. 

• Ensures timely regulatory actions (registration of new products, line extensions, variations, renewals and any other required) of assigned product portfolio with the most competitive label in line with business/R&D objectives. Coordinate the local Health Authority meetings and committees internally (Dry runs) and with the local Health Authority.
• Maintain strong, open relationships with cross-functional stakeholders and brand teams in providing regulatory guidance to create a credible, respected, and influential regulatory function.
• Ensure compliance to the local Health Authority requirements regarding import, commercialization, distribution and trade of pharmaceuticals.
• Responsible to maintain and strengthen communication and interaction with the local Health
• Authority. External networking with Trade associations if assigned as a Director Backup in associations.
• Maintains a healthy work environment with sensitivity to the balance between personal and professional life and develops people and organization.
• Ensure the regulatory systems compliance in alignment with the timelines defined.

• At least 5 years prior Regulatory Affairs experience in a management position in Mexico.
• Pharmacist, Biotechnology Engineer, Pharmaceutical Engineer or related demonstrable professional degree
• Demonstrated strong Regulatory Authority interactions at a senior level, ability to negotiate.
• Good documentation practices, Pharmacology among others).
• Strong knowledge in Health regulation in Mexico.
• Fluent in English written and spoken.
• Experience working and leading multi-disciplinary Project Teams.
• Strong leadership attributes and skills.

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.