Sofía Arias Sancho

Regulatory Affairs Specialist (Nov 22- Present)

• Appointed as acting Project Lead during maternity leave (Jul 24-Nov-24), overseeing critical regulatory activities across Central America and the Caribbean (CAC). Also, providing technical and administrative support for Project Team members and being contact point between Regulatory Affairs Manager and Project local Team and Global teams for specific topics when needed.
• Built strong relationships with global regulatory counterparts to accelerate decision making and facilitating efficient information exchange on regulatory strategies for over 7 on going global projects across time zones and teams
• Design and executed regulatory strategies for the lifecycle maintenance and implementation of pharmaceutical products across the region, ensuring on time and in compliance submissions and product availability
• Achieved an average of 10 successful submissions per month, maintaining a high first cycle approval rate with minimal authority observations
• Received "Leading Performer" on 2024 recognition for outstanding contribution to regulatory excellence, team work, and strategic alignment
• Review and prepare technical, legal and scientific information to submit regulatory dossiers as per local authority guidelines
• Optimized internal processes for timely submission of regulatory documentation to authorities
• Advised strategic regulatory observations and risk management to leadership, aligning global and local objectives and optimizing project timelines and priorities
• Collaborated as regulatory representative with multidisciplinary teams (including global, suppliers, distributors, government, quality, commercial, medical affairs, and supply), driving cross-functional alignment and proactive risk mitigation
• Reviewed and approved promotional and educational materials for compliance with regulatory and ethical standards across multiple CAC markets
• Ensured accurate and timely documentation in global and regional regulatory systems according to the company's SOPs: RIMS, D2, MIRT, SAP, Excel
• Developed internal trainings on regulatory compliance to colleagues on regulatory requirements, resulting in increased awareness and overall compliance
• Enhanced regulatory compliance by developing, improving, and implementing standard operating procedures and work instructions for internal procedures such as artwork&labeling, medical devices requirements, and branding transfers, boosting process clarity and regulatory alignment.
• Interpreted regulatory updates and communicated with others through corporate policies and procedures.
• Leadership on internal initiatives promoting health awareness and continuous education by launching a bi-monthly internal newsletter sharing curated course opportunities and learning resources; also introduced the therapeutic card game Vaso Terapia to encourage emotional well-being and open conversations among colleagues.

• Planning of regulatory strategy for the registration and maintenance of pharmaceutical products in Costa Rica.
• Preparation of technical and legal documentation for regulatory submissions: new registrations, renewals and post-registration changes.
• Elaboration of the labeling project and monographs for verification of compliance with local regulations and updated scientific information.
• Support in proposed post-registration changes and regulatory impact analysis.
• Participation in pre-qualification and maintenance processes of products at the institutional level: Costa Rican Social Security Fund (CCSS) and National Insurance Institute (INS).
• Communication and collaboration with external and internal entities of the company.

• Review of technical, legal, and scientific documentation for submission to Health Authority.
• Submission of new licenses for pharmaceutical products in Central America.
• Follow-up to post-registration changes of product registered in Costa Rica.
• Management of procedures related to products with Bioequivalence.
• Preparation of Monographs and Local Inserts based on technical sheets of Reference Authorities for submission in the region.

• Development of Risk Management Plan to be used in the region.
• Creation and implementation of a Local Electronic Pharmacovigilance Report.
• Support to Medical Affairs department on regulatory and pharmacovigilance information.