About Freyr Freyr Solutions is a leading global Regulatory Solutions and Services company supporting Life Sciences organizations across pharmaceuticals, biologics, medical devices, and consumer healthcare industries. Freyr partners with global clients to deliver specialized regulatory, compliance, and operational support across worldwide markets. Job Title: Regulatory Affairs Specialist Location: Mexico - Remote Employment Type: Full-Time/Indefinite Role Overview The RA Specialist is responsible for all aspects of regulatory submissions in the assigned markets. Critical to this role is to combine knowledge of scientific, and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on expertise in regional regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity. The Specialist is responsible for all regulatory submission requirements for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations as well as company SOPs. Key Responsibilities Assist in development of product registration plans & strategies and working cross-functionally to align & communicate the submission plans. Support maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications, site transfers, importation, distribution, tender related activities and supplemental marketing authorizations in accordance with local regulations and global standards. Maintain and archive regulatory documents in accordance with department and company policies and local requirements. Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues. Assists in improving local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluates processes for potential improvement in efficiency and effectiveness. Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders. May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Quality and supply chain to avoid supply constraints and ensure constant audit-readiness. As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply-chain. Tasks Technical change management including dossier preparation and compilation Label updates and artwork maintenance Agency requests with post-marketing samples Documentation and archiving of dossiers Maintenance of internal regulatory systems Competencies Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed. Demonstrates advanced skills to drive change and champions development. Delivers with accountability: Aligns strategic priorities to team priorities and team resources and delivers results in accordance with timelines and appropriate regulations. Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes. Innovates with agility: Encourages diverse thinking and experiments with new ways of working. Demonstrates advance skills in problem solving using creative thinking, aligning with stakeholders to responds to new, complex, or problematic situations. Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks. Communicates with optimism and authenticity: Articulates a compelling shared vision and communicates with empathy. Demonstrates advanced oral and written communications and presentation skills. Makes timely and appropriate decisions and to determine when escalation of issues is necessary. Activates belonging: Reinforces diverse representation and consideration in all talent selection and development activities across teams. Qualifications & Experience Skills (Professional and/or Technical) Excellent communication and time management skills, the ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently across markets. Ability to effectively negotiate and influence management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met. Experience Minimum of 5 years of industry experience in regulatory affairs and/or CMC. Expert knowledge, understanding, and application of principles, concepts, and practice of regulations across ASEAN markets. Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio. Education / Certificates The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken). What We Offer Opportunity to work with global pharmaceutical clients. Exposure to international regulatory environments and submissions. Collaborative and growth-oriented work environment. Opportunity to work on high-impact global regulatory projects. Why Join Freyr At Freyr Solutions, you will work alongside industry experts supporting complex global regulatory programs for leading Life Sciences organizations. Freyr offers an opportunity to contribute to critical regulatory and CMC initiatives while building expertise in global pharmaceutical compliance and submission standards.