Presentación
The Site Regulatory Affairs Associate is responsible for the operational and document management of regulatory affairs within the Quality Unit of the Menarini plant in L’Aquila. The role focuses on ensuring regulatory compliance, managing site documentation, and handling changes or deviations with a regulatory impact. This person must be a determined, dynamic, and authoritative professional with strong leadership and communication skills, dedicated to achieving objectives through a lean approach and a continuous improvement mindset. The role reports functionally and hierarchically to the Quality Unit Manager at the Menarini L’Aquila plant.
Organización
You will work at a prominent Italian pharmaceutical company with a global presence and a solid track record of over 130 years in the industry, located in Badalona. With a team of more than 700 professionals in Spain, they are among the top 15 pharmaceutical companies in the country. Their current focus covers key areas such as cardiovascular risk, respiratory, analgesia, male sexual health, and the digestive system. Additionally, they are committed to research and development of new products in various therapeutic areas, including oncology.
Función
Main Activities & Responsibilities Regulatory Compliance & Document Management ● Management of aspects inherent to regulatory compliance, specifically site regulatory documentation preparation and processes. ● Preparation of technical registration documentation. ● Management and support for Change Controls and deviations with a regulatory impact. ● Direct collaboration with the Global Quality Management team for regulatory compliance aspects, ensuring the exchange of necessary documentation. Quality System Support & Audit Participation ● Functional support for the activities of the Qualified Person (Persona Qualificata) and the Quality System of the Menarini L’Aquila production plant. ● Direct participation in internal and external (national and international) audits, supporting all activities related to regulatory compliance. Quality System Monitoring & Continuous Improvement ● Participation in Supplier Qualification and Process Validation activities. ● Monitoring of CAPAs and Quality System KPIs, driving continuous improvement activities. ● Drafting and verification of documentation concerning the corporate Quality System.
Requisitos
Job Requirements Education ● Degree in technical/scientific disciplines (preferably CTF – Pharmaceutical Chemistry and Technology, Pharmacy, or Chemistry). ● English language proficiency: minimum B2 level (fluent written and spoken). Additional Knowledge & Skills ● Strong orientation toward goal-driven work and a «lean» approach. ● Analytical mindset, problem-solving skills, and planning capabilities. ● Proficiency in using software for spreadsheet processing and statistics. ● High sensitivity to Quality KPIs and continuous improvement methodologies. ● Excellent interpersonal and communication skills, flexibility, and willingness to travel.
Oferta
What We Offer Competitive salary (dependent on experience) and a discretionary incentive scheme. Defined pension contributions (3% employee contribution, 10% Company contribution). Private healthcare provision (AXA) and dental insurance (Den plan). A hybrid role with working hours of 37.5 hours per week. 25 days holiday each year plus 8 bank holidays, with the ability to bank holidays for future use. Personal death in service insurance (4x salary). Join us and become part of a tradition of excellence and innovation. Apply now!