Senior Manager, Regulatory Affairs

Summary

Join Biogen's dynamic Regulatory team as a Sr. Manager, Regulatory Affairs, focusing on Latin American North (LAN) and International Growth Markets (IGM). Spearhead local regulatory activities in Mexico and Colombia, playing a strategic role in early-stage pipeline development, submissions, and lifecycle management of registered products. Your contributions will be instrumental in clinical, labeling, and CMC strategies, ensuring alignment with regional regulatory frameworks. Drive compliance and facilitate effective product launches and market presence. Navigate the complex landscape of pharmaceutical legislation, interfacing with key stakeholders. Report directly to the LATAM Regulatory Senior Director.

Requirements

• Bachelors Degree, Master's preferred
• At least 5 years of experience in Regulatory Affairs in Mexico. Experience in Colombia a plus
• Health-related sciences background
• In-depth knowledge of Mexican pharmaceutical legislation
• Proven ability to interpret local regulations and influence operations accordingly
• Track record of achieving fast-track registration in Mexico and Colombia
• Experience with regulatory authorities (COFEPRIS and INVIMA) and effective interactions with regulatory agencies and corporate partners
• Rapid assimilation of new knowledge and understanding of cross-functional drug development processes
• Strong analytical skills, with a focus on accuracy and reliability
• Demonstrated strategic thinking and risk assessment capabilities
• Fluent in Spanish and English (required)

Responsibilities

• Develop and execute registration strategies in Mexico and Colombia, aligned with regional business objectives and timelines
• Forge and enhance relationships with global, regional, and local stakeholders, ensuring effective support and communication
• Provide insights and strategic guidance on local regulatory matters, influencing the direction of submissions and market approaches
• Lead regulatory submission activities for new products and manage lifecycle activities for existing products within the region
• Coordinate and oversee dossier submissions to achieve timely approvals from Drug Regulatory Agencies
• Ensure regulatory compliance for all marketed products, managing licensing, labeling, and CMC commitments
• Manage and direct the labeling and artworks development process, ensuring adherence to SOPs and local regulations
• Actively monitor and communicate regulatory commitments and changes to key partners and colleagues
• Maintain up-to-date regulatory intelligence, interpreting local guidelines and anticipating their impact on operations
• Build and sustain robust relationships with regulatory officials and represent Biogen in local industry associations and regulatory forums
• Provide regulatory input and guidance across corporate functions, fostering a proactive and collaborative environment

Preferred Qualifications

• Experience in additional LATAM markets
• Demonstrated leadership and interpersonal skills
• High emotional intelligence and a collaborative decision-making approach
• Exceptional organizational and project management skills
• Effective presentation skills and confidence in communication