Descripción del Puesto / Job description
Working within a local project team, the Local Regulatory Affairs Specialist will be responsible for the regulatory activities of medicinal products and medical devices, ensuring their registration and market entry in compliance with current legislation and company requirements.
Provide support and coordination for medicines and medical devices projects to ensure compliance with Local Regulatory Affairs (LRA) functions in Spain.
Determine regulatory strategy / estimate submissions timelines and all necessary authorizations.
Lead engagement with Health Authorities / Notified Bodies.
Collaborate with different teams at ITF Group and external parties (from Affiliates to Distributors) to establish processes and communication flows, anticipate potential obstacles during product launch, and develop solutions to ensure compliance at a local level.
Principales responsabilidades / Key Responsibilities
1. Act as the Regulatory Affairs representative for the planning of regulatory activities, ensuring compliance with timelines and quality of documentation for Medicinal Products / MDs registration.
2. Management and prioritization of multiple and complex projects, timelines, and objectives within a matrix team environment.
3. Preparation and management of registration dossiers / variations for medicinal products and medical devices, ensuring technical accuracy, maintenance and regulatory compliance, to meet local registration objectives throughout the life cycle of the products.
4. Development and maintenance of standard operating procedures (SOPs) related to regulatory activity.
5. Working with a multinational and cross-functional team, ensuring the harmonization of policies and procedures.
6. As LRA-ES specialist, work closely with the GRA MD Lead to guarantee the correct Technical Documentation (Technical File) for the maintenance, and expansion of the MDs when Spain is the reference country.
7. Determine and execute actions necessary for new product registrations and change notifications to ensure that ITF SA complies with local registration requirements and business objectives are met.
8. Compile comprehensive scientific information for use in regulatory submissions through coordination with other departments, research of documentation and guidelines in such a manner to facilitate the registration process.
Requisitos del puesto / Job requirements
1. Bachelor’s degree in pharmacy, Health Sciences or any other discipline linked to Medicinal Products and Medical Devices registration / market authorisation.
2. At least between 3-5 years of related regulatory and / or technical experience in the industry and / or pharmaceutical manufacturing companies, with experience in Medicinal Products and Medical Devices Regulatory department.
3. Experience working with Health Authorities and Notified Bodies to obtain the CE mark under MDR.
4. Experience with the pre-clinical, clinical, chemistry, manufacturing and controls of pharmaceutical products and / or e-submissions and regulatory information management experience.
5. Knowledge of applicable laws and regulations.
6. Proficiency with Microsoft Office.
7. Strategic thinking, collaborative leadership, analytical, responsible, good communication and teamwork skills.
8. Fluent spoken and written in English (C1 Level).
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