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

Regulatory Strategy and Compliance

• Develop and implement new assets regulatory strategies for the assigned product portfolio with the most competitive label in line with business/R&D objectives incompliance with local, regional, and international regulations. Coordinates the internal preparation, rehearsal and readiness for the local Health Authority meeting (New Molecular Committee).
• Oversee the implementation of regulatory maintenance strategy for the assigned product portfolio.

Documentation and submissions management

• Oversee the preparation and submission of regulatory documents for new assets such as new drug applications (NDAs) and marketing authorization applications for devices (MAAs) and ensure that all regulatory maintenance preparation and submissions follow the applicable regulatory guidelines and standards.
• Identify potential regulatory risks and develop mitigation strategies to address them proactively and conduct risk assessments and ensure that regulatory risks are communicated effectively to senior management

Cross functional collaboration

• Maintain strong, open relationships with cross-functional stakeholders and act as a brand team regulatory representative by providing regulatory guidance to create a credible, respected, and influential regulatory function.

Regulatory Intelligence and Advisory

• Responsible for maintaining and strengthening communication and interaction with the local Health Authority. External networking with Trade associations if assigned as a Director Backup in associations.

Core Job Responsibilities

Regulatory Strategy and Compliance

• Develop, implement, and update regulatory strategies for new assets to ensure compliance with evolving global & local regulations. Analyze regulatory environments and develop strategies to optimize regulatory pathways for new assets approvals and ensure all products comply with applicable regulations, guidelines, and standards, including GMP certifications.

• Develop, update, and coordinate the regulatory strategy for the new products/projects in collaboration with the Brand teams and Area Therapeutic Area Teams and local stakeholders, as well as that all regulatory processes will be met to ensure a successful launch. Including the internal coordination and readiness of New Molecules Committee.
• Budget planning for the assigned product portfolio aligned to the annual submission plan.

Documentation and submissions management

• Oversee the preparation and submission of regulatory documents for new assets such as new drug applications (NDAs) and marketing authorization applications for devices (MAAs).
• Oversee the implementation and ensure that all regulatory maintenance projects and submissions follow the applicable regulatory guidelines and standards. Supervise team coordination actions with internal teams to gather necessary data and ensure timely submission of all regulatory filings.
• Oversee the compliance with the local Health Authority requirements regarding importation, commercialization, distribution and trade of pharmaceuticals and medical devices.
• Oversee the maintenance and organization of the regulatory documentation and correspondence, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Oversee that the regulatory systems are compliance in alignment with the timelines defined.
• Identify potential regulatory risks and develop mitigation strategies to address them proactively and conduct risk assessments and ensure that regulatory risks are communicated effectively to senior management.

Cross functional collaboration

• Lead cross-functional teams in the development and execution of regulatory strategies and plans for new assets projects and oversee the plans for regulatory maintenance.

• Provides support in the certification of Manufacturing Sites for GMP's inspections.
• Responsible for the application of effective processes and quality standards for advertising and Promotional (A&P) review process in line with company & external policies.
• Provide proactive regulatory guidance throughout all stages of product development and post-marketing (including advertising and promotion).
• Know, adopt, and transmit our culture, philosophy, and Leadership attributes according to the AbbVie way, all behaviors must be aligned to our Ethic and company policies and become an AbbVie culture ambassador.

Team Management and Development:

• Lead, mentor, and develop a team of regulatory professionals, ensuring team members are trained and updated on regulatory knowledge and skills.
• Assign tasks, manage resources, and evaluate team performance to achieve departmental goals. Foster a collaborative team environment that encourages continuous learning, knowledge sharing, and professional growth.

Position Accountability / Scope

Internal Areas:

Medical, Regulatory Affairs, Commercial, Market Access, Supply Chain, Quality Assurance, Demand Area and Finances (for the budget preparation and maintenance), PSP, Communication, legal; this list is enunciative and not limitative, any other interaction area required may be included in the scope.

External Areas:

Mexican National Regulatory Agency (COFEPRIS), industry associations and A&AS Area (Area and Affiliate Support)

Minimum Education

Pharm D, Bsc Chem, Biotech Engineer or related field of study.

Master of Pharmacology or Business Administration or related field of study desirable.

Minimum Experience / Training Required

• 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.
• Robust technical knowledge (e.g. analysis of stability data, quality controls, good manufacturing practices, 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 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