Regulatory Affairs Senior Specialist

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• You have a Bachelor's Degree in Health Sciences or engineering.
• You have experience in RRAA or technical departments within the pharmaceutical industry.
• You have analytical skills, attention to detail, and ability to summarize and evaluate.
• You have Advanced level of Spanish and English (C1) and of MS Office (Excel).

Ensuring compliance of the priority plan, as well as coordination of compilation, submission and following up of product registration and/or renewal and/or changes/variations dossiers, and any other regulatory documentation, within the company timelines. Determine and execute actions necessary for licenses and regulatory procedures are in compliance with domestic and international licensing requirements

• Assess and define worldwide regulatory strategies for product registrations, renewals, and lifecycle management activities across assigned products and markets.
• Review, prepare, and submit regulatory dossiers for new registrations, renewals, variations, and other post-approval changes, ensuring compliance with applicable regulations.
• Prepare, review, and coordinate responses to Health Authority questions and requests within established timelines.
• Manage and coordinate the adaptation of product licenses to current regulatory requirements and evolving legislation.
• Coordinate and approve packaging materials and labeling documentation, ensuring regulatory compliance and alignment with local market requirements.
• Organize, coordinate, and supervise the work of Regulatory Affairs Technicians, ensuring the timely and high-quality execution of assigned activities.
• Review and assess the regulatory impact of product, manufacturing, or process changes within the assigned portfolio and oversee the implementation of required regulatory actions.
• Monitor and supervise the execution of annual regulatory projects and ensure deliverables are achieved according to agreed timelines.
• Represent the Regulatory Affairs function in communications with affiliates, external partners, and Health Authorities, when applicable.
• Maintain up-to-date knowledge of applicable regulations and regulatory requirements, providing regulatory guidance for different projects and business initiatives.
• Support general activities and strategic initiatives within the Regulatory Affairs Department.
• Coordinate the preparation, review, implementation, and maintenance of Regulatory Affairs Standard Operating Procedures (SOPs).
• Collaborate with cross-functional teams to ensure efficient regulatory support throughout the product lifecycle.