Regulatory Affairs Latam 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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

The Manager, Regulatory Affairs Area develops and executes Latin America regulatory strategies & key deliverables for development compounds and marketed products in alignment with the overarching global regulatory strategy and in collaboration with the Global and Affiliate Regulatory colleagues. S/he represents Area on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and properly maintain regulatory applications to Health Authorities across the Area. This role also interfaces with partner functions (e.g., Commercial, Market Access, Quality Assurance) to ensure Regulatory strategies are aligned with business objectives.

Major Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Develops the regional Regulatory Strategy Plan in collaboration with affiliates to support the development of compliant and competitive Regulatory programs.
• Manages the preparation and review of regulatory submissions consistent within LATAM Regulatory requirements and guidelines to drive complete and timely information to Health Authorities.
• Represents the Area& Affiliate in  GRPTs and interacts with other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program.
• Effectively communicates country-specific regulatory requirements to GRPT, provides guidance, and other relevant regulatory intelligence to SMEs to ensure these are incorporated into Regulatory submissions across the Area.
• Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area.
• Represent Area Regulatory on the Cross-functional teams by providing strategic input for registration, ensuring the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product.
• Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.
• Represents the Area regulatory team in regional and global process improvement initiatives;. Able to lead regional initiatives
• Leads team meetings effectively; appropriately escalates and drives issues to resolution; demonstrates good negotiation skills, effective group facilitation skills, and ability to drive consensus among team members.
• Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential deliverables for a variety of audiences.

Required Education:  

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or industry related field

Preferred Education:  

• Advanced degree(s) a plus
• Certifications such as RAC from the Regulatory Affairs Professionals Society

Required Experience:  

• 3-5 years’ industry  experience in the LATAM Regulatory environment. In-depth knowledge the regional regulatory requirements and ability to interpret regulations.
• Proven leadership skills and presence
• Experience interfacing with government and health authorities
• Experience working in a complex and matrix environment

• Strong verbal and written communication skills
• Ability to work with cross-functional teams
• Ability to interact with different levels of stakeholders
• Strong attention to detail and problem-solving skills
• Strong project management skills
• Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks
• Keen awareness to cultural nuances; proven ability to work in a global environment. Able to work flexibly across a variety of countries, products and projects with increasing complexity and/ or size

• Ability to successfully interact with multi-divisional and multi-functional teams from across the globe

Note: Higher education may compensate for years of experience; years of experience may compensate for education

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.

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