Regulatory Affairs Specialist

ID: 2550 Date of Posting: May 8, 2026 Business Area: Regulatory Affairs Job Type: Direct Employee On site / Remote / Hybrid: Hybrid Hub Office: Territory: Full-Time or Part-Time: Full Time Seniority: Mid-senior With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. Job Purpose We are looking for a Regulatory Affairs Specialist to join the International Corporate Regulatory Affairs team, responsible for managing regulatory activities for SPC medicinal products for human use. Responsibilities include obtaining and maintaining marketing authorizations in the European Union (through CP/MRP/DCP) as well as supporting regulatory activities in various non-EU regions, including Africa, Asia Pacific, CENAM, CSI, LATAM, MENA. Key Responsibilities The candidate will be responsible for the preparation, review and submission of regulatory documentation to Health Authorities, as well as for the management of regulatory data and documentation within relevant electronic systems, in support of: • New Marketing Authorisation Applications Line-extension, • Renewal of Marketing Authorizations • Variations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation • Marketing Authorization transfers • Notification of start and end of marketing • Requests for Sunset Clause exemptions • Review and approval of printed materials (artworks and mock-ups) • Request for Notified Body Opinions Based on the products assigned, the Regulatory Affairs Specialist will also: • Define regulatory activity plans and related costs • Collaborate with cross-functional teams to define and manage timelines for the preparation of regulatory submissions • Contribute to the management of core dossiers, including gap analysis activities, to support registrations across multiple international markets, in collaboration with relevant departments • Coordinate with the group's affiliates, licensees and consultancy companies • Maintain relations with the Regulatory Authorities • Monitor the legislation in force and assure the regulatory compliance • Provide regulatory assessment for new business opportunities Required Education • Scientific Degree • Master in Regulatory Affairs (preferred) Required Skills and Experience More than 5 years of experience in Regulatory Affairs within multinational pharmaceutical frims (ideally at "parent companies") or international regulatory consulting companies Experience with the EU Centralised and Decentralised Procedures Background in OTC product development and lifecycle management High level of autonomy in managing assigned activities Technical Competencies In-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical devices Experience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform) Required Behaviours and Competencies • Positive and proactive mindset, with a solution‑oriented approach • Strong communication and collaborative skills, team‑player attitude • Effective time management and organisational skills • Flexibility and adaptability in a dynamic environment • Strong work ethic Required Languages Fluent in English At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.